INTRODUCTION:

Healthcare is one of the most important factor and sector directly connected with the wellbeing of its people. The importance of health care can be well determined from the fact that in our country it is acknowledged as a fundamental right of any citizen. Any nation is required to spend quite a substantial amount for development of health care facilities for its people. However, in a country like India where a major portion of its population lives below the poverty line, devoid of even bare basic necessities of life, it is not merely sufficient to provide access to healthcare facilities but it is also more important to provide healthcare and medicines at a cheap and economical price in order to enable every person to be able to meet the basic healthcare and medical needs.

In spite of government spending quite a substantial amount on drug research and innovation for development of healthcare in India and as a result the pharmaceutical market is growing but the cost of medicines specially those of basic life-saving drugs and medicines is showing a steep increase, so much so, that it is becoming nearly impossible for a common man of the country to be able to afford their costs. According to the NSSO, 70% of out of pocket expenditure on health is due to medicines and this is a major access barrier to healthcare especially for the poor. The total healthcare spending of people is increasing, thereby straining their budget and way of living as well as even forcing a majority of poor population to have no access to basic and essential medications.

The need for low cost and affordable medicines for the people is gaining importance and the innovation in form of generic medicines as a substitute for high cost medicines has come as a great savior for most of the people. Unfortunately, though the significance of generic medicines have been recognised since long time in a country like ours and it is most essential need for today, the generic medicines are neither being prescribed nor their use being publicized and nor they are available generally in open market.

Nearly all drugs have three types of names, the International Union of Pure and Applied Chemistry (hereinafter referred as IUPAC), the non-proprietary or generic, most commonly the International Non-proprietary Name (hereinafter referred as INN) administered by the World Health Organisation (hereinafter referred as WHO), and the brand name. Some countries such as the United States of America (hereinafter referred as USA), Britain and Japan have their own generic names or approved names. However, the term generic has a different meaning in India’s pharma trade. Medicines marketed exclusively with INN names are called generics or generic medicine.¹

A generic drug is defined as a drug product that is comparable to a brand/ reference-listed drug product in dosage, strength, route of administration, quality and performance characteristics and intended use.² Apart from this, the brand producing a new molecule gets a patent to be able to have selling rights. Once a drug loses its patent protection, it can then be produced by several other drug manufacturers and is called a ‘generic’.³

A generic medicine uses the same active ingredients or chemical component as brand medicines and is the same in terms of safety, effectiveness, strength and quality. These are marketed without brand names and in spite of being chemically identical to branded drugs, are 10 to 90 % cheaper than them.⁴ The branded drug manufactures mostly invent a drug, then get it patented and spend lot of money on their advertising and marketing while for the generic medicine manufactures no such cost is incurred as the formula and chemical components of drug is already known and their effectiveness and trials are completed, as such generic medicines are available much cheaper.⁵

It is appreciable that in U SA, before a company starts manufacturing generic drug it has to file an application termed Abbreviated New Drug Application (hereinafter referred as ANDA) before the Food and Drug Administration (hereinafter referred as FDA) and is required to prove that the generic drug is chemically equivalent to the branded drug. Besides this, the FDA constantly and periodically carries out inspections of generic medicine pharmaceutical company plants to ensure their effectiveness, safety and quality.⁶ Moreover, the FDA ensures ample supply of generic drugs in the market and in the USA, out of every 10 prescriptions filled, 9 are of generic medicines.⁷

In India, a generic medicine is sold directly by a chemist to the patient on demand. Thus, if a doctor prescribes ‘Paracetamol tablets’ of a particular brand name the patient has the option to buy that particular brand name medicine or if he asks the chemist for ‘Paracetamol tablet’ of particular strength, he can get the same for a much cheaper price which would be generic, having the same effectiveness, composition and other particulars. In our country especially where poverty is vast spread along with expensive healthcare facilities, the cost of medicines is a very vital factor and as such generic medicines gain much importance. However, the factor which has also to be kept in mind is that a generic medicine of good quality can be a substitute for brand medicine in terms of cost and effectiveness but the quality of generic medicine is also a prime factor. The branded medicines are manufactured under strict quality control, desired temperature conditions and other factors which influence affectivity of the product are often kept in mind. Thus, while generic medicines can be equally good but they should have been manufactured under desired conditions and with an eye on quality of the medicine.⁸

Thus if the quality of generic medicine is maintained in a country like India, it can prove to be of immense importance, revolutionary and a boon. Life-saving drugs in our country come at a very high price and generic medicines can provide an easy and affordable access to all specially for life saving medicines.⁹

The cost difference is very considerable and cannot be ignored in a country like India. For example, the drug 'Glivec’ used for treating chronic myeloid leukemia or in other words cancer, manufactured by Novartis, a Swiss Pharmaceutical Company, comes at a price of approximately 1.2 lakh per month dose while its generic equivalent is available for as low as Rs. 8000/- per month.¹⁰ This is important because in our country, as per the statistics, around 10 lakh people are diagnosed of cancer every year out of which unfortunately 7 lakh die mainly due to high cost of treatments.¹¹

Thus, the importance of generic drugs is not only associated with public interest for financial and economic aspects only but also for safety as well as treatment of vast spread fatal diseases like Cancer and AIDS etc., including many generic medicines or formulations for diabetics, antibiotics, hypersensitivity and blood pressure problems.

In this regard, another equally important aspect is vital to pursue. India is frequently referred to as ‘pharmacy of the world’ and is the 11th largest pharma market in the world and will rise to ninth position by 2022. Over 40% of its domestic output (by value) is exported to several countries. It accounts for 20% of the global supply of generic medicines, 60% of all vaccine supply and 80% of all antiretroviral drugs used against HIV/AIDS.¹² At present, India shares 35% of the world's generic drug market with high tech testing, research and biotechnology available in the country, the growth of generis medicines is going to be beneficial also for the pharmaceutical industry in the country specially keeping in view that the generic drug market globally is expected to reach 380.60 billion dollars by 2021 which was only 200.2 billion dollars in 2015. This would boost the Indian drug industries as well as subsequently the economy of the country.¹³ Thus, the importance of generic medicines are multifold and a few can be summarized as the -

· Saving in terms of money for the consumers by buying generic drugs;

· Competition between pharmaceutical companies for supplying cheaper medicines would benefit customers in India;

· Export of generic medicines in market worldwide by companies in India would benefit them as well as economics of the country;

· Spirit of innovation and research etc., would be generated in manufacturing as well as quality maintenance; and

· Customers would have options to buy cheaper medicine of their choice for life-threatening fatal diseases.¹⁴

Generic drugs by way of effective quality control are found to be safe for patients and with number of growth of patients and various infections and diseases in India where cost factor is important aspect generics are an asset and blessing in disguise.

GENERIC MEDICINES and THE PATENTS ACT, 1970:

The patent system provides a technical framework within which the manufacturing activities can be established either by the patentee himself or by way of grant of a patent licence. In India in statutory terms, “patent means a patent for any invention granted under this Act.¹⁵ By granting patent, it is presumed that it will it will help industrialization, modernization, technological advancement of the country as well as serve the human kind and the whole universe.

Till the year 2004, in cases of foods and drugs, the patent was provided only for process used for manufacturing particular product but not for product itself, and the process patents were also granted for short period of 5 to 7 years.

This bar was removed by the TRIPs Agreement and the scope of patentability in TRIPs Agreement has been greatly enlarged. Now the patents shall be available for any invention whether products or processes in all fields of technologies provided that they are new, involve an inventive step and are capable of industrial application.¹⁶ The Agreement provides that the term, i.e., period of protection which shall not end before the expiration of a period of twenty years counted from the filing date. Under the TRIPs Agreement, this term of 20 years would be globally applicable. There will be no varying the period of patent term as at present in the national laws of developing and developed countries.¹⁷ Since patentability extends to products and processes, the term would be applied for twenty years for product patent and then twenty years for process patent particularly in the chemical field including drugs and pharmaceuticals.¹⁸

This provision is being misinterpreted and cleverly misused by the pharmaceutical companies for unjust enrichment. As per existing law, patents offer their owners market exclusivity for a limited period of time. For medicines, this exclusivity should last as long as the primary patent which relates to the Active Pharmaceutical Ingredient (hereinafter referred as API) of the medicine is in effect, typically for 20 years. The end of patent exclusivity is referred to as a patent cliff, because drug prices fall steeply afterwards by as much as 80% owing to generic competition.¹⁹

But the threat of this precipitous fall in profits drives pharmaceutical companies to find new ways to postpone their exclusivity by filing secondary patents for derivatives and variants of the API, such as physical variant of the API, a new formulation, a dosage regimen or a new method of administering the medicine. The secondary patents prop up before the expiry of a primary patent thereby stretching the exclusivity beyond 20 years and this practice is called “ever greening of patents.²⁰

The United States frequently recognizes and encourages secondary patents. In the cases of medicines, patents are available in USA for usage form, dosage form and combinations and the same would be extended to other countries. Under this system, new processes would be patented and new dosage form etc., would also be patented. These kinds of protection have greatly affected the availability of the generic medicines as well as availability of medicines at competitive prices.

However, things changed in 2005 because in order to fulfill its obligations under the membership of world Trade Organization and under the Trade Related Intellectual Property Rights, the country had to provide for patents for product also along with processes.

This provision allowed the pharmaceutical companies in India to flourish, as it developed low cost medicinal substitutes for high cost western medicines and sell then in international market without infringing the law if the process of manufacturing of such medicines was slightly different from process of patent holder company.²¹

As such, the Government of India first brought about the Patents (Amendment) Ordinance in 2004 and later replaced it with Patent (Amendment) Act, 2005 from 1st January 2005. The provision which mainly effected the drug industry under the 2005 amendment was the introduction of Section 3 (d) which provided that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant".²²

Thus, it became necessary that in order to allow a patent of a new form of a known product or substance, the new form must enhance the effectualness of that substance to a significant degree.²³ Under the new law of 2005, the first product patent was granted in March 2006 to the pharmaceutical company Roche, for its drug 'Pegasys' in India. Further the Patent Amendment Act of 2005 also extended the product patent period to 20 years instead of earlier 5 years.²⁴

Though, the amendments of 2005 were discouraging initially for the generic market and manufactures, the production of generic medicines have risen in last few years. This is because any company, who gets a patent for any of its product, can only continue to have so for 20 years (but in practice they are extending them in usage form, dosages form and combination form) and after that it would loosen its right on patent and the generic medicine manufactures can step in.

By use and application of Section3 (d), secondary patents for several blockbuster medicines have been rejected by the Indian Patent Office expanding access to medicines for important health problems such as Cancer, AIDS, Asthama and Cardiovascular diseases including the rejection of a secondary patent for Novartis ‘Glivec’, a crucial leukaemia cure was famously upheld by the Supreme Court of India in 2013.²⁵

Such type of check and control has become possible only due to some remarkable amendments in the Patents Act, 1970. Primarily, inventions are treated as the main subject-matter of the patent. Under the Patents Act, 1970 ‘invention’ means a new product or process involving an inventive step and capable of industrial application.²⁶ For the purpose of patent protection, the product in question must feature a technical advance over what came before that’s not obvious to a person skilled in the art.²⁷ When a medicine is merely a variant of a known substance, it necessitates a demonstration of improvement in its therapeutic efficacy. This provision also restricts patents for new uses and new properties of known substances and promotes generic medicines.²⁸ Similarly, Section 3 (d) and (i) ensures that no exclusivity can be claimed over mere admixture and method of treatment. All these provisions of the Patents Act, 1970 are instrumental to check unethical practices of the pharmaceutical companies which are the major hurdle in production of generic medicines.

Taking serious cognizance of access to medicines, the World Health Organisation has now invited expression of interest from drug manufacturers to produce generic versions of expensive drugs.²⁹

Apart from these, ‘Compulsory Licensing’ (hereinafter referred as CL) is a mechanism permitted by the Trade Related Aspects of Intellectual Property Rights (hereinafter referred as TRIPs) Agreement to enable countries to issue licences to domestic drug manufacturers to produce and market affordable generic versions of lifesaving drugs needed for meeting serious public health challenges that are of extreme urgency.

A report of the UN High Level Panel Access to Medicines (2016) called upon countries to safeguard and fully utilize the rights conferred by the TRIPs flexibilities as confirmed by the Doha Declaration of the WTO. The UN report also urges member states of WTO to adopt a permanent revision of Paragraph 6 of the TRIPs Agreement to enable “swift and expeditious export of pharmaceutical products under compulsory licence”.³⁰

Under the provisions and allowance provided by Trade Related Intellectual Property Rights, compulsory licensing is allowed under which a company holding intellectual property right of a product can be bound to licence out their right to any third party who is interested, without the patent owners consent. This spirit has been incorporated under the Indian Patents Act, 1970 where at any time after expiry of 3 years from date of grant of patent, any interested person may make an application to the Controller for grant of compulsory licence on patent on the ground of reasonable requirement for public with respect to the patented invention have not been satisfied, or that the patented invention is not available to public at a reasonably affordable or that the patented invention is not worked in the territory of India, the same can be granted to the applicant in public interest.³¹

This is a boost for manufacturers of generic medicines determined to supply substitutes of high cost medicines at low price having same effectuality and quality as well as composition.

The first such compulsory licence was granted in India to Hyderabad based pharmaceutical company Natco for making medicine for kidney cancer which would cost Rs. 8880/- for 120 tablets as against Bayer Company’s drug Nexavor which costs Rs. 2.8 lakh for 120 tablets or Cipla version costing Rs 28000/- for the same.³² This provision has boost generic market and manufacturing and would help in treatment of fatal diseases like Cancer, Tuberculosis and AIDS. Many generic substitutes for high cost vaccines have also been granted compulsory licence.

Section 3(d) of the Patent Act, 1970 as amended in 2005 can also be conceived in order that it boosts the generic drug industry and protects interest of people who have to depend on availability of low cost drugs and interpreted accordingly so as to favour both the generic manufacture as well as innovators in order to collectively secure public health.³³ On the face of it, while Section 3 (d) seems to be against the up rise of generic market or secondary patents yet if it is used to reduce hordes of primary patents, it would make generic medicine manufacturing, marketing and availability easier, which is required for the Indian societal conditions.

GENERIC MEDICINES: THE WAY AHEAD:

Due to sustained efforts by the government to put in place a legal framework to promote generic medicines, the Medical Council of India issued a directive in September 2016, making it mandatory by amending the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 to prominently mention the generic names of drugs along with brand name in prescription.³⁴ There is an advisory to State Drug Controllers that all braded drugs, imported or domestically manufactured, should mandatorily have generic names mentioned in bold while packaging.³⁵

It is significant to observe that the ‘Code of Ethics’ of the ‘Medical Council of India’ itself stipulates that every physician should as far as possible prescribe drugs with generic names.³⁶ More importantly, later this ‘Code of Ethics’ was amended to provide that "every Physician should prescribe drugs with generic names legibly and preferably in capital letters."³⁷ Thus, the Council itself which governs quality medical care to all citizens through its member physicians is of the view that the doctors must always prescribe generic medicines in order to ensure health care at affordable prices to all.

The government on the other hand also is putting in a lot of efforts to promote prescribing of generic medicines by the physicians compulsory. Specifically, the Prime Minister in his speech delivered on 17th April 2017has assured about bringing a legal framework under which the doctors would have to prescribe generic medicines.³⁸ The Government of Himachal Pradesh has already set up plans to make it compulsory for all doctors in the hospitals to prescribe medicines only by its generic names.

An initiative to ensure affordable medicines through dedicated outlets was launched in the name of the Pradhan Mantri Bhartiy Janaushadhi Pariyojna (hereinafter referred as PMBJP) in 2008. The mission was to aware about generic medicines and provide commonly used generic medicines and health care products. However, as on March 31, 2012, only 157 stores were opened and later, many became non-functional. Till the end of 2014-15, there were only 99 stores.³⁹

On this front way back in 2014, a ‘Strategic Action Plan’ was prepared by launching the ‘Jan Aushadi Scheme’ for making quality medicines available at a lower price for the indigent and poor from specially opened outlets of ‘Jan Aushadi’. Under this scheme while ‘Jan Aushadi Stores’ were opened in some districts across the country in September 2015, this scheme was given a new structure as 'Pradhan Mantri Jan Aushadi Yojna' and later in November 2016 as 'Pradhan Mantri Bhartiya Janaushadi Pariyojna'.⁴⁰ However, practically this initiating has failed to have the desired effect due to inadequacy of supply of generic medicines as well as mismanagement at these stores and non-compliance of directions by the doctors who continued to prescribe branded medicines.⁴¹

While the prescribing and marketing of generic drugs would be of great benefit to the public at large reeling under lack of proper and affordable health care, there are many hurdles and issues to be crossed and overcome. Firstly, the doctors, pharmaceutical industry and medical stores which form a chain of deep rooted corruption and are making hordes of money by manufacturing, selling and prescribing high cost medicines are opposing this move of the government at the cost of inconvenience and burden on patient and people of the country as their illegal money making sources would get adversely effected.

In order to overcome this problem, a strict legislation which would enforce mandatory prescribing of medicines by their generic names as well as punishment for not doing so, has to be brought in force urgently but this is not being done as it seems that the governments are also playing in the hands of strong pharmaceutical industry setup.

Secondly, the generic medicine manufacturing industry needs to be revamped and restructured by issuing more licenses to upcoming proposed generic drug manufacturers. Further, a strict quality control in manufacturing of generic drugs has to be ensured and enforced. Many commonly used generic medicines in the country are failing in quality tests frequently.⁴²

India is one of the major exporters of generic medicines. A research and assessment of 1470 samples of antibiotic and tuberculosis generic drugs done a few years back by Roger Bate of American Enterprise Institute found a very high fraction of these samples to be of poor and sub-standard quality. Incidentally in 2014, the United States Food and Drug Administration and the United Kingdom Medicines and Health Care Products Regulatory Agency rejected some imported generic drugs from India after they failed the purity and dissolution tests.⁴³

A recent report on five year performance audit from 2011 to 2016 in India too issued by the Comptroller and Auditor General of India reveals that the generic drugs supplied by government hospitals are of substandard quality. Shockingly, around 32% of the drugs supplied for armed forces were also found to be of poor quality. Many generic medicines are also unavailable in the government hospitals.⁴⁴

In this regard, it is instructive to look at the findings of recent Report on sub-standard and spurious drugs by the National Institute of Biologicals for the Central Drugs Standard Control Organisation. The Report established that branded medicines are in no way assurance of quality. It was based on the drug survey conducted from 2014-2016 in which 47954 samples of drugs were collected from across the country and put to test. The Report revealed that while 13 samples (0.024%) were spurious, as many as 1850 samples (3.16%) were sub-standard. It also showed that while in retail outlets 3% of the medicines were sub-standard, in government pharmacies the figure was a staggering 10%.⁴⁵

As many as 26 out of 46 samples (56.52%) from Pfizer (a big name in the pharma industry) were found to be sub-standard in the survey.⁴⁶ Apart from Pfizer, 23 samples of Cipla Limited (other famous brands) from different manufacturing units across were found to be substandard. Dr. Reddy Laboratories Limited had 9 substandard samples, while Zydus Healthcare Limited had 6 substandard. All six out of sis samples of generics Mercury Laboratories Limited from Gujrat were substandard.⁴⁷ It shows that big brands are no guarantee of good quality.

According to the United States and European Union researches made in the context of generic drugs, these drugs can be made equivalent to the innovator or branded drugs by making ‘bioequivalence testing’ of them compulsory which would be a certification of quality and standard for generic medicines. Even the World Health Organisation purchases only those generic drugs which have passed the bioequivalence test.

The Health Ministry of India has also amended the Drugs and Cosmetics Rules in April 2017 making it compulsory for all drugs to be tested for bioequivalence. As a practical way, what is required strictly is not only to bring a legal provision for testing and ensuring of standard of generic drugs but also to publish for benefit of patients and public the information on qualities of generic drugs and their test results by way of a strong national database.⁴⁸ The Ministry of Health and Family Welfare must also strengthen its nodal agency Central Drugs Standard Control Organisation and set up more testing laboratories in all States across India.⁴⁹

As well as institutional commitments, administrative control and ethical norms are concerned, the Medical Council of India (hereinafter referred as MCI) has failed on its part to control or restrict physicians to prescribe medicines by their generic names only despite having included this Protocol in its own ‘Code of Ethics’, the government too has failed on its part to create awareness and a sense of right among the people of the country with regards to use and advantages of generic medicines instead of branded drugs for their own good. The generic medicines are mostly beneficial for the poor people of the society but the government has not taken up any awareness programmes, seminars and advertisements etc., in cities or villages to make people apprised or informed in any way about low cost generic drugs. Even the ‘Jan Aushadhi Schemes’ have not been properly implemented. Drastic steps are needed on the part of the States and Central Government to make people aware of the existence of affordable generic medicines, to ensure their availability in medical stores and government hospital and put an end to the flourishing illegal doctor-pharma nexus.⁵⁰

Most of the healthcare professionals are aware of generic medicines as the studies in Medical colleges and Nursing Training Centers etc., contain a general study of salts needed for cure of particular ailments and diseases but while they fail to carry out their duties towards the public by prescribing generic salt compositions and not creating awareness about the advantages of generic drugs.

The recent studies made in this regard in our country reveal the bitter truth. For example, a study conducted on 60 Medical Interns, 30 Doctors, 50 Nurses, 50 non-medical staff like Clerks and Attendants and 100 patients shockingly disclose that while all medical persons like Doctors, Nurses and Interns knew about generic drugs, only 60% of non-medical staff was aware of it and around 95% of patients had absolutely no knowledge of generic drugs. Also 70% of patients depended on what brand name of medicines were prescribed by doctors and never asked for another branded or generic drug.⁵¹

Another recent study about assessment of doctors perceptions and understanding about generic medicines and their knowledge, attitude and practice reveals that while 62.9% doctors agreed that generic medicines are interchangeable with branded drug, 77.5% were also aware that generic drug manufacturers ought to conduct bioequivalence test of generic medicines in context of their branded counterparts. 88.8% doctors also acknowledged that the importance of generic drugs must be taught in internships while 80.9% doctors felt that changing a patient's medication from branded to generic may change the outcome of therapy.⁵²

The way ahead to intensifying use and popularity as well as availability of generic drugs in India is full of obstacles which need to be overcome at all stages in a combined and co-ordinated effort by the government, pharmaceutical companies, physicians and pharmacists as well as the society and all this can be well achieved as a start by bringing an effective legislation in this regard and imposing strict quality assurance, bioequivalence tests and effectiveness studies/researches on generic brands and manufacturing units and by creating awareness programmes both at city as well as at village levels for society at large.

JUDICIARY AND GENERIC MEDICINES:

The legislature has to think in terms of bringing about the laws regarding manufacturing, use and quality control of generic drugs and the government has to create awareness, availability and planning aspect of generic drugs. Judiciary has little to do with it except in cases brought before it under the Patents Act, 1970 or on related issues.

Ample availability and spread of awareness about generic drugs is an integral part of healthcare. In Consumer Education and Research Centre v. Union of India,⁵³ the Apex Court has held that right to health is an integral part of a meaningful right to life and right to healthcare and medical facilities are a fundamental right under Article 21 of the Constitution of India.⁵⁴

The provisions of granting compulsory license under the Patents Act, 1970 to promote promotion of low cost generic drug substitutes for costly branded drugs is a beneficial provision. Bayer, the pharmaceutical company supplied patented Nexavar drug for kidney and liver cancer which was very costly and out of reach of common ailing person in India. Thus, when Natco Pharma Limited applied for compulsory license for manufacturing of generic substitute at low cost for this drug, the government allowed the same in public interest. On Bayer Company's objection to this, the Controller of Patents approved the granting of licence to Natco Pharma, which decision was also upheld by the Intellectual Property Appellate Board.

Subsequently, in a petition under Article 226 of Constitution of India by way of Bayer Corporation v. Union of India,⁵⁵ the Bombay High Court held that the mandate of Parliament for providing a compulsory licensing was that medicine has to be made available to every patient and this cannot be sacrificed at the altar of rights of patent holder. The entire basis of compulsory licence is based on the objective that patented article is made available to the society in adequate numbers and a reasonable price. These are matters of public interest. The public interest is and should always be fundamental in deciding alis between the parties while granting a compulsory licence for medicines/drugs.⁵⁶

The ‘Code of Conduct and Ethics’ of the Medical Council of India, 2002 stipulates that the practitioners must prescribe medicines by their generic names. This direction is not being followed by even the practitioners of government hospitals. In a petition filed by an aggrieved patient in this regard by way of Vijay Mehta v. State of Rajasthan and others,⁵⁷ the Rajasthan High Court, vehemently pointing out this fact and observed that it is imperative as per Regulations of 2002 framed by the Medical Council of India which have a statutory force that the doctors should prescribe the medicines as for as possible in generic names. The Court noted that in spite of such direction being issued by the State of Rajasthan itself, this mandate is being flouted by obtaining declarations from the patients that they don't want prescription of medicines under generic names. Obtaining of such declaration amounts to violation of Regulations framed by MCI and is also an unethical practice for which the concerned doctor must be held liable for disciplinary action. The Court further held that at national level, provision has been made to prescribe medicines in generic names in para 4.11.1 of the National Health Policy and that prescribing of generic drugs is a perquisite for cost effective public health care.⁵⁸

The Court in the instant case was of the view that "doctors prescribe the medicine by writing first word 'Rx’. The nobility of profession cannot be destroyed by bringing commercial element and making it a business activity to cater to commercial interest of pharmaceuticals by prescribing medicines in brand names. Such tendency to violate the ‘Code of Ethics’ is against the spirit of dignified profession dealing with general life.” The Court also said that there is unholy link between doctor and pharmaceutical company and the ultimate sufferer is the poor ailing persons who has to purchase the medicines at much higher rates than he can afford.⁵⁹

Thus even when, the MCI is not able to successfully implement its own directives, the courts have to come to rescue of the poor sufferer patients in dire need of generic low cost medicines. It is however true that there are several medicines for which the generic substitutes are not available or yet launched in the market and as such to bind the pharma shops in a government hospital for keeping only generic medicines would be detrimental to public interest. This fact was well pointed out by the Delhi High Court in South Delhi Distributors v. Government of NCT Delhi and another ⁶⁰, wherein it was said that though there is no doubt that the efforts to provide quality medicine at affordable price is not only laudable but is essential and needs to be encouraged and implemented in the right spirit yet the efforts to provide only generic drugs at hospital complex to the exclusion of all other medicines may defeat the very purpose for which ‘Jan Aushadhi Scheme’ has been launched and as a result the patient seeking treatment at public hospital would be deprived of a facility of chemist shop in respect of several medications for which generic formulations are not available in the market as well as other required surgical implants and implements.⁶¹

On the basis of above study, it can be said that while the judiciary has mostly settled disputes between pharmaceutical companies relating to patent or infringement of patent, however, whenever and where ever it was called upon to settle suits relating to generic drugs, it has always given importance to the fact that for a poverty ridden society like ours, an affordable healthcare option is vital and must be encouraged as for as it does not infringe the right or patents of pharmaceutical companies.

CONCLUSION:

In recent years, India has played an increasingly important role in the production of generic drugs to transform healthcare in the country. Inspired by the objective of ensuring that everyone, everywhere can access essential quality health services without facing financial hardship, our country has taken the vital steps towards availability of generic medicines by attempting to strike a fine balance between the health interests of consumers and the financial health of pharmaceutical companies.

The government has been focusing on making medicines affordable by making them available through Jan Aushadhi Kendras, enabling price control of essential medicines, promoting prescription of generic medicines by medical practitioners and focusing on a conducive intellectual property regime.

Generic drugs tend to cost less than branded ones. A serious threat to affordability of medicines comes from big global pharmaceutical firms/companies. These companies and their governments have been trying to lobby with India to make patent protection more stringent despite the fact that both compulsory licencing and prohibition of ever greening, provided under the Indian Patents Act, 1970 are valid under the TRIPs Agreement. Keeping in mind that health is one of our fundamental rights has resisted any change in its intellectual property laws that can have the effect of making medicines unaffordable.

While the government from its end has been pushing hard on this front, the Medical Council of India has also made it compulsory for the physicians to prescribe medicines only by their generic names and the National Health Policy is also concerned with growth of generic medicines in India, all these efforts are so for have not gained achievement on this front. The doctors, relentlessly carry on prescribing medicines by their brand names, the availability of generic medicines as a substitute for costly branded ones is almost nil be it the government hospitals or the chemists. Moreover, the illegal and unwanted pharmaceutical company’s pharmacist-doctors nexus continues to thrive at the cost of harassment to the public who is forced to buy branded costly drugs for their health care mostly unaffordable for them.

The judiciary in this regard is helpless as it can only enlighten or direct the government to do their best in this relation. The legislature has amended the Patents Act, 1970 providing for compulsory licencing to those applying for licence for manufacturing of generic substitutes for costly lifesaving branded drugs after three years of patent of branded medicine having expired and some advancement in manufacturing and availability of generic medicines with help of this provision has of course been achieved, yet this step alone does not seem to be enough.

Further, the vital steps required are to bring about a strong legislation not only compelling the doctors to prescribe medicines by their generic names but also to provide for fines and punishments in case they fail to do so. Besides this, most of the generic substitutes available for branded costly drugs are of substandard and poor quality and a compulsory bioequivalence test has to be enforced for their quality control assurance. It has also to be ensured that the government hospital, pharmacies and chemists in the market must have at all times ample stocks and availability of generic medicines.

Most of the people in our country need to be made aware of importance and the very aspect of existence of low cost generic medicines and to achieve this the government needs to initiate awareness programmers, seminars and group discussions under the National Health Policy at every district, city and village level not only for the public but for chemists and doctors as well. The ‘Jan Aushadhi Scheme’ ought to be given immense lift and boost too by opening more and more such ‘Jan Aushadhi Kendras’ in every State, district and cities.

So, the core issues are affordable access to medicines and their rational prescription and use. These objectives require an enlarged list of essential and life-saving medicines under price control. Now the debate about drug safety and generic prescription of drugs has polarized, all stakeholders admit that the Prime Minister’s announcement and commitment has opened a discussion about affordable medicines that was a need of the hour.

REFERENCES:

1. George Thomas and S. Srinivasan, “What’s in a generic name?”, The Hindu, May 12, 2017.

2. Neelam Mohan, “Getting the generic drug plan right”, The Hindu, July 8, 2018.

3. Ibid.

4. See, "Generic Drug Facts", available at, https://www.fda.gov, last visited on 09.12.2018, see also, “Medical Definition of Generic Drug", available at, at https"//www.medicinenet.com, last visited on 09.12.2018.

5. Ranit Mishouri, "Why are generic drugs cheaper than brand-name ones", available at, https://www.washingtonpost.com, last visited on 09.12.2018.

6. See, https://en.wikipedia.org/wiki/Generic-drug#UnitedStates, last visited on 09.12.2018; see also, supra note 4.

7. See, "Generic Drugs-FDA", available at, https://www.fda.gov, last visited on 09.12.2018.

8. Ashok Pangariya, "Generic Medicines in India: The myth and the truth behind the healthcare issue", available at, https://www.firstpost.com, last visited on 11.12.2018.

9. E. Kumar Sharma, "Dying to Survive: Indian generic medicines have a tale to tell", available at, https://www.businesstoday.in, last visited on 11.12.2018.

10. Puskar, “Generic Drugs-why is it important?", available at,greencleanguide.com/generic-drugs/, last visited on 12.12.2018.

11. See, "Cancer Kills 7 lakh people in India every year: the health ministry is fighting back", Think Change India,September20, 2017, available at, https:// yourstory.com, last visited on 12.12.2018; see also, "1300 die of cancer every day in India", available at, http//: www.ndtv.com, last visited on 12.12.2018.

12. Ranjana Smetacek, “Lessons from a neighbor”, The Hindu, September23, 2018.

13. Ajay Bera and Ashish Mukherjee, "The Importance of Generic Drugs in India", 2(4) The International Journal of Pharmaceutical, Chemical and Biological Sciences.575-577 (2012); see also, "Global Generic Drug Market Size and Share to Reach $380.60 Billion by 2021: Zion Market Research”, March 21, 2018, available at , https://globenewswire.com, last visited on 15.12.2018.

14. Kanika Tripathi "How Promotion of Generic medicines can play important role in cost effective treatment in India?", (August 24, 2018), available at, https://www.drishtifoundaiton.org, last visited on 15.12.2018.

15. Section 2 (1) (m), The Patents Act, 1970.

16. Article 27.1, TRIPs Agreement.

17. Id., Article 31.

18. Id., Article 33.

19. Feroz Ali and Sudarsan Rajagopal, “Biologics, patents and drug prices”, The Hindu, February 8, 2018.

20. Ibid.

21. George T. Haley and Usha C .V. Haley, "The effects of patent law changes on innovation: The case of India's pharmaceutical industry", available at, https://www.researchgate.net, last visited on 17.12.2018; see also, https://en.wikipedia.org/wiki/generic-drug, last visited on 17.12.2018.

22. Section 3(d), The Patents Act, 1970 as amended by Patent (Amendment) Act, 2005.

23. Supra note 10.

24. Section 53, The Patents Act, 1970 as amended by Patent (Amendment) Act, 2005.

25. Supra note 19.

26. Section 2 (1) (j), The Patents Act, 1970.

27. Id., Section 2 (1) (j a).

28. Id., Section 3 (d).

29. K. Srinath Reddy and Shaktivel Selvaraj, “An urgent prescription”, The Hindu, March 14, 2018.

30. Ibid.

31. Section 84 and 92A, The Patents Act, 1970.

32. See, "India's first compulsory licence granted to Natco for Bayer's Cancer Drug", available at, https://www.thehindubusinessline.com, last visited on 18.12.2018.

33. Shalini Arora and Rekha Chaturvedi, "Section 3 (d) : Impicaitons and Key Concerns for Pharmaceutical Sector", 21 Journal of Intellectual Property Rights 17-18 (2016).

34. Gopal Krishna Agarwal, “Road map to affordable medicines”, The Hindu, November 18,2018.

35. Ibid.

36. Section 4 (1.5), Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.

37. Id., Clause 1.5 substituted by notification published in the Gazette of India on 0 8-10-2016.

38. Gudipati Rajendra Kumar, "Making prescription of generic drugs mandatory”, available at, https://www.thehansindia.com, last visited on 20.12.2018; see also, “PM Modi says govt. will bring law to push doctors to prescribe generic medicines”, available at, https://www.hindustantimes.com, last visited on 20.12.2018.

39. Supra note 34.

40. See, https;//en.wikipedia.org/wiki/Pradhan-Mantri-Bhartiya-Jan-Aushadi-Yojna-Kendra, last visited on 20.12.2018; see also, Home site of PMBJP Scheme available at, janaushadi.gov.in, last visited on 20.12.2018.

41. See, "Reality Check: Jan Aushadi Kendra no relief to most patients", available at, https://www.tribuneindia.com/news, last visited on, 21.12.2018; see also, “Govt.’s medicine scheme falls sick”, The Indian Express, June 24, 2017.

42. Supra note 38.

43. Sanjeet Bagcchi, “Indian generic drugs debate heats up", Vol. 384 Issue 9951 The Lancet, 1334 (2014).

44. Koride Mahesh, "CAG's damning data: No quality control on drugs", The Times of India, March 28, 2017.

45. Jyotsna Singh, “Can doctors judge quality of medicines?’, The Hindu, May 14, 2017.

46. Ibid.

47. Id.

48. Dinesh S. Thakur and Prashant Reddy T., "Generic Medicines in a digital age", The Hindu, April 29, 2017.

49. Songja Engti Kathar, "Before the Govt. Makes Generic Drugs Mandatory, it needs to address these issues", available at, https://www.youthkiawaaz.com, last visited on 21.12.2018.

50. Rumani Saikia Phukan, "Generic Drugs in India: More Awareness Required", available at, https://www.mapsofindia.com, last visited on, 21.12.2018.; see also, supra note 38.

51. Sahana K. Hebbar, G. K. Nalini, Deepak P. Sahana, G. N. Jayshree and V. Nagarwal, "Assessment of awareness on generic drugs among health care professionals and laypersons", Vol. 6, No.3 International Journal of Basic and Clinical Pharmacology 681-682 (2017).

52. Rohini Gupta, Apoorva Malhotra and Pavan Malhotra, "A study on assessment of awareness on generic drugs among doctors in a tertiary care teaching hospital in North India", Vol. 6, Issue 4 International Journal of Research in Medical Sciences 1363 – 1365 (2018).

53. AIR 1995 SC 922.

54. Id., at paras 20-24, 26 and 27; see also, State of Punjab v. Ram Lubhaya Bagga, (1998) 4 SCC 117.

55. Writ Petition No. 1323/ 2013 decided on 15th July 2014.

56. Id., at para 13 and 19.

57. Writ Petition (Civil) No. 3031/2007 decided on October 10, 2011.

58. Id., at para 19 and 22.

59. Id., at para 24 and 25; see also, Medical Council of India v. State of Karnataka, AIR 1998 SC 2423.

60. Writ Petition (Civil) No.11847/2009 decided on December 15, 2009.

61. Id., at para 7.43.

Received on 17.05.2019 Modified on 24.05.2019

Int. J. Rev. and Res. Social Sci. 2019; 7(2): 405-414.

DOI: 10.5958/2454-2687.2019.00033.9