Abhishek Gupta
Introduction
The government has often mooted the idea to mandate medical professionals to prescribe generic medicines. Last year, the parliament introduced the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023 (“ Regulations”) with the aim to ensure affordable healthcare to the people of the country. Despite the medical advancements made by the country, the rural areas and the economically weaker section still did not have easy access to life saving medicines. This was attributed to the profit liaison between doctors and pharmaceutical agents to prescribe medicines belonging to a particular brand. The government, in order to address the issue, brought the Regulations, which mandated prescription of generic drugs which are considerably cheaper than their branded counterparts making them affordable and more accessible. These generic drugs have the same active chemical ingredient as the innovator drug. However, it is argued that mandating medical professionals to prescribe generic medicines is in contravention of Right to Health under Article 21 of the Constitution. These regulations faced strong opposition from the medical community, following which the government put on hold the impugned regulation until further notice.
The article will delve into the how Right to Health is enshrined under Article 21 of the Constitution of India and then highlight how mandating generic medicines risks the health of the patients due to regulatory loopholes in the drugs regulation in India and is therefore violative of Right to Health.
Right to Health under Article 21
The Supreme Court of India has interpreted Article 21 to include the Right to Health, even though this right is not expressly recognised in the Constitution. The preservation and enhancement of public health are recognised by the Court as basic rights under this Article. In addition, the Constitution’s Directive Principles of State Policy (DPSP) give the state an obligation to improving public health a primary duty. Even if they are unenforceable, the DPSPs are essential to the nation’s governance and provide a way to evaluate the legality of state acts.
The Supreme Court of India, in the case of Vincent Panikulangara v. Union of India, held that “maintenance and improvement of public health have to rank high as these are indispensable to the very physical existence of the community and on the betterment of these depends the building of the society which the constitution makers envisaged. Attending to public health is therefore of top priority.” By mandating generic drugs, the government may disregard this duty and might endanger public health.
Right to affordable health and right to quality care are two aspects of the same right i.e., Right to health. The scope of right to health as delineated by judicial precedents carefully balances the two aspects and finds a middle ground for the same keeping in mind the right of people to have quality and affordable treatment and the financial constraints on the state. In case of Mohd. Ahmed (minor) v. Union of India, the Delhi High Court held that under right to health, every person has a fundamental right to quality healthcare that is affordable. Mandating generic drugs may make the drugs affordable and more accessible, however it compromises on the quality and safety of the drugs as has been argued further.
The court in the same case also ruled that in case of rare and chronic diseases, the government is under obligation to provide free treatment to the patient even if the treatment is recurring and expensive. In Deepa Pant v. State of Uttarakhand,the Uttarakhand High Court held that it is the responsibility of the state government to provide life-saving drugs free of cost. However, the court has also recognised the financial constraints on right to health and held that the right is not absolute. Therefore, the court has adopted a flexible approach while interpreting right to health.
It is argued that mandating medical professionals to prescribe only generic drugs endangers the public health for three reasons: firstly, generic medications may not have the same therapeutic effect as branded medications; secondly, there is no quality control for generic medications; and thirdly, it puts the onus of prescribing drugs to the pharmacists who may prescribe a drug of his choice which may put the health of the patient at risk.
I. The therapeutic effect of generic drugs may differ from the therapeutic effect of branded drugs
Generic drugs may have the same chemical composition as the innovator drug but they might have different therapeutic effects on the patients. Generic drugs have the same active chemical ingredient but may differ in excipients/inactive ingredients. Any variation in the way the drug was formulated or in the use of excipients or compression/milling can have a material effect on the treatment outcomes in the patient. Poor quality of excipients reduces the absorption of the drug in the blood leading to varying amounts of the medicine reaching the site of action in the body hindering the medication’s intended therapeutic impact. Thus, even with chemical equivalence, the drug’s bioavailability may differ from that of the innovator drug.
Additionally, there is evidence to imply that laboratory-established equivalency may not necessarily correspond to bioequivalency in people. The drug absorption profile of these drugs may be similar, but they may not be therapeutically equivalent. Another study points out that the use of generic drugs could be related with increased days of disease or might lead to therapeutic failure. In March 2021, Nycup syrup was found to have lower levels of the active ingredient by testing agencies. But regulatory action was limited, with the regulator finding it challenging to build a case against the manufacturer.
Even the Delhi High Court, in the case of Hoechst Pharmaceuticals v. C.V.S. Mani, noted that “we cannot accept the contention that there is no difference in formulations made by different formulators for the same bulk drug.” The Court also remarked that “it is common knowledge and is well supported by medical opinion that two patients may react differently on taking the same drug.” Doctors through their clinical experiences know that their patients might respond to certain branded drugs only. In such a case, when doctors are forced to prescribe generic drugs, it can harm the patient by depriving them of the best treatment and infringing on the doctor’s professional autonomy.
II. There is no quality check of generic drugs
The Drugs and Cosmetics Act, 1940, and the Drug and Cosmetics Rules, 1945 are archaic laws that control drug regulation in India. The existing drug regulation in India does not guarantee a standard quality of the pharmaceuticals for two reasons: firstly, a considerable number of the drugs on the market have not passed bioequivalence testing, and secondly, a considerable number of drugs have not undertaken stability testing.
a. A considerable number of drugs have not undergone bioequivalence tests
The issue of bioavailability of different brands of drugs was flagged by the Hathi Committee Report on pharmaceuticals and the pharmaceutical industry as early as in 1975. However, action was taken only in 2001 when Form 44 and Appendix 1A were inserted to the Drugs and Cosmetics Rules, 1945, requiring bioavailability/bioequivalence tests as a prerequisite for licensing of generics.
However, it did not apply retrospectively and only required bioequivalence data submission to the DCGI for an initial four years while the drug maintained its ‘new drug’ status. After this period, the applications shifted to state drug controllers, who did not require bioequivalence proof. As a result, generic manufacturers could obtain marketing approvals without submitting their own bioequivalence data, relying instead on research data submitted by the pharmaceutical companies (manufacturing the drug).Only in 2017, did the government bring the Drugs and Cosmetics (Ninth Amendment) Rules, 2017. These revisions require bioequivalency testing for certain types of generic medications, even if the producer plans to use already submitted research data to regulators by other pharmaceutical firms in order to get a licence under the Drugs and Cosmetics Rules. On the contrary, the Hatch-Waxman Act, 1984 of USA placed the concept of ‘bioequivalence’ as one of the central tenets of the act from its inception.
b. A considerable number of drugs have not undergone stability tests
Apart from bioequivalence, the other critical problem with the generics is the issue of stability testing with the generics. For instance, renowned pharmaceutical company Ranbaxy was convicted for failure to comply with the ‘stability testing’ of drugs supplied in the USA. The drug regulation laws mandated that ‘new drugs’ were required to submit stability data to DCGI since 2001, however after the expiry of four-year period there was no requirement to submit such data to state drug regulators. It was only in 2018 that the stability testing of all generic drugs was made compulsory by Drugs and Cosmetics (Third Amendment) Rules 2018.
It is not clear whether the new bioequivalence and stability applies retrospectively, meaning that formulations approved before the regulations have not been tested for bioequivalence or stability. Since most of the drugs have been approved before 2017 and 2018, it means that majority of the drugs in the Indian market have not undergone these tests, thereby putting the health of the public at risk. There are many instances of generic drugs leading to adverse consequences. There have been links to children’s acute renal damage caused by generic cough syrups manufactured in India to 70 fatalities in Gambia and 68 deaths in Uzbekistan in 2022. Moreover, there is evidence to suggest that pharmaceutical companies have at times fabricated test results to get their drugs approved. One of the most prominent cases is that of Ranbaxy where the company pleaded guilty for providing false data to the US drug regulation agencies.
Taking these factors into account, requiring medical practitioners to prescribe generic versions of medications compromises patients’ health by denying them access to appropriate medications and supplying them with substandard medications.
III. The onus will shift from the doctor to the pharmacist who may prescribe the drug of his choice
The common rationale given while mandating generic medicines is that it will reduce public expenditure on health. The assumption is that the pharmacists filling the prescription containing only generic names will pick the lowest priced brand of the drug. However, it is very much a possibility that the pharmacists may prescribe a drug that entails maximum profit for him thereby defying the purpose of the mandating generic drugs. As has already been discussed above, different patients react differently to the same drugs. Therefore, a doctor is best-placed to cater to each patient’s individual needs and prescribe a suitable medicine for him. Putting the onus on pharmacists to prescribe a brand of medicines of his choice whether generic or branded can put the health of the patient at risk.
Conclusion
The solution to the problem of branded versus generic lies in strengthening the existing drug regulatory and quality control structure. The strategy can be two pronged with an increase in the capacity of existing testing laboratories and opening up of new laboratories in government colleges. Pharmacology departments of existing medical colleges can play a big role in this direction. India can also learn a lot from how other countries have dealt with the issue of doctor-pharma nexus. For instance, USA has the Physicians Payments Sunshine Act, 2010 which is a law to increase transparency of financial relationships between doctors and pharmaceutical companies. It requires drug manufacturing companies to report data on gifts and payments given to doctors, which is then made publicly available. In India, we have a similar code – Uniform Code of Pharmaceutical Marketing Practices (“UCPMP”), which was brought with the aim to prevent pharmaceutical companies from extending monetary and non-monetary benefits to healthcare professionals. However, the code lacks tooth since it does not specifically mention that it is mandatory. It merely requires the companies to do a self-declaration. The code could be further strengthened to effectively address the issue of doctor-pharma nexus. Therefore, the government must strengthen the existing testing capabilities and must make it mandatory for pharma companies to report data on gifts and payments given to the doctors.
Another issue that needs to be addressed is that some states like Himachal Pradesh and Uttarakhand are hub for NSQ Drugs (Not of Standard Quality). Both the states account for a major chunk of medicines in India since these states have some tax incentives which make them an attractive drugs manufacturing hub. Due to the spurious drugs produced by these states, other states who import such drugs have to suffer. It is therefore suggested that firstly, the drug regulation in such states be made more rigorous and secondly that drugs subject to inter-state trade are subjected to oversight by a central regulator.
Therefore, considering that majority of the drugs have not passed the bioequivalence and bioavailability tests, it is necessary that the government must not mandate healthcare professionals to mandate generic medicines else the health of the public will be put at risk and violate their right to health under Article 21. Moreover, the government should ensure that the drug regulation laws are strictly implemented so as to ensure that there is no production of spurious drugs.
The author is a fourth – year student at the National Law University, Delhi.
NUALS Law Journal 