Anshumaan Tandon and Satyam Mehta
The Hon’ble Supreme Court, while hearing a Public Interest Litigation [“PIL”] seeking regulation of unethical marketing practices by pharmaceutical companies, observed that if there existed a statutory mandate requiring doctors to prescribe only generic medicines, the issue could be effectively resolved.
In response, the Union Government relied on the NMC [National Medical Commission] Registered Medical Practitioner [“RMP”] Regulations, 2023, which not only prohibited doctors from prescribing branded medicines but also imposed numerous other restrictions. However, following the opposition from the pharmaceutical lobby and medicinal practitioners, who raised concerns about the quality of the drugs and inadequacies in the healthcare infrastructure – the regulations were withdrawn. They have now re-emerged in public debate.
This article delves into a constitutional analysis rooted in the practical and legal implications of these regulations and their suitability for the Indian medical and healthcare sector.
Article 19(1)(g) and the Scope of Reasonable Restrictions
The analysis logically begins with Article 19(1)(g) which gives every citizen the right to “practise any profession, or to carry on any occupation, trade or business”. This right, however is subject to restrictions under Article 19(6).
Article 19(6) itself stipulates that the restriction has to be placed in the general interest of the public. Thus, the initial inquiry into the constitutionality of such restrictions must examine whether they serve public welfare – particularly whether the right to health is being upheld or violated. In Vincent v. Union of India, where the right to health was first articulated, it was held that injurious drugs should be completely removed from the market. Similarly, in Swami Achyutanand Tirth v. Union of India, the right to health was enforced against FCI and FSSAI to improve the quality of the edible products available. These cases raise an important question: if the right to health demands quality assurance for edible goods, can the law compel the prescription of generic drugs, an essential commodity in a country lacking the infrastructure to ensure their quality?
Concerns Regarding Generic Drug Standards
Numerous stakeholders have expressed concerns regarding the quality of generic medicines. The generic medicines manufacturers are not required to comply with the stringent FDA standards, but, are instead held to the much more relaxed Schedule-M standards. Bio-equivalence means that two drugs are effectively the same in terms of their effect and the main ingredient. Some of the generic drugs do not even have to prove bio-equivalence. This, in turn, amplifies the risk. In any case, we don’t have the regulatory mechanism capable of verifying such bio-equivalence.
Investigative reports further suggest that production of generic drugs does not result in truly interchangeable medications. This calls into question the reliability and therapeutic equivalence of generic drugs in the absence of robust regulation.
Directive Principles and the Boundaries of Reasonableness
When it comes to the markers of reasonableness in fulfilling the public’s interest, the courts have often referred to the Directive Principles of State Policy (DPSPs). In this context, Article 47 can be cited to justify regulatory action. However, as observed in Mohd. Hanif Quareshi & Others v. The State Of Bihar, even if a DPSP is being fulfilled, it cannot be done so in an unreasonable manner.
In any case, the legal fiction at work here is that the legislature has kept the DPSPs in mind while legislating. In other words, the courts will assume that the legislature has kept the DPSPs in mind while legislating and it is the intention of the legislature to give effect to these DPSPs. The laws are interpreted in accordance of this assumption. However, a critical issue arises when the legislative interpretation of a right diverges from the judicial interpretation. In such instances, the regulation must yield to a fundamental right. Yet, it is also true that DPSPs have been used to interpret the scope and content of fundamental rights. This dichotomy necessitates a more nuanced enquiry.
Legitimate Nexus and Proportionality
The next step in the test of reasonableness involves two pronged analysis: whether the regulation has a rational nexus with its objective and second, if it is a proportionate measure. It must be examined if a less drastic measure could have been employed to achieve the desired objective.
It is arguable that the regulation has a legitimate nexus with its objective-curbing unethical pharmaceutical practices. However, it shifts the regulatory burden from pharmaceutical companies to doctor. This just shifts the malefaction from the doctors to the pharmacists, as the pharmacists can be bribed in order to promote a particular product. Moreover, this is even more dangerous as pharmacists are not as qualified as doctors to assess the actual effects of the drug purported to be promoted.
Stringent Control over the Profession
The above-mentioned issue is compounded as the regulations stipulate that an RMP shall not “whether for compensation or otherwise, any approval, recommendation, endorsement, certificate, report, or statement concerning any drug brand …” this provision is wide enough to cover even a statement made in good faith advising a patient regarding a drug.
Additionally, the regulations provide that the RMPs shall not attend any conference directly or indirectly sponsored by a pharmaceutical company. However, doctors are mandated to attend a minimum number of conferences organized by government authorities which are likely to advocate for generic medicines. While RMPs are forbidden to engage with pharmaceutical companies for advertisement of drugs, it is not only permitted for the government to be in a position to endorse generic medicines, but RMPs are also mandated to attend such events.
Now, we must examine whether these regulations are absolutely necessary to achieve the objective and are in the public interest. As discussed earlier, the state of India’s regulatory and healthcare infrastructure undermines the argument that the regulations are wholly in the public interest. In this analysis, both limbs of the proportionality test must be applied in tandem: the public interest must be evaluated alongside the effects of the regulation on individual rights, as contemplated by Article 19(6).
It is pertinent to mention that the conferences are now being regulated through the UCPMP regulations since the NMC regulations were withdrawn. In any case, the collective effect of these provisions is that the entire discourse is controlled for an invariable push towards generic medicines with patients being left at the Pharmacist’s mercy. It is certainly not a proportional measure to achieve the desired result, as is evident by the much less stringent UCPMP regulations. Perhaps the embargo on doctors to even advise the patients can be limited to only unsolicited cases. But then, would that be stretching the limits of right to information or right to health too far, where the patient must have at least some autonomy over what alternative he chooses. The patients cannot be presumed to know what generic medicines are or their potential concerns. Therefore, even a liberal interpretation would have a deterrent effect on the rights of the patients. Keeping in consideration the lack of infrastructure to ensure the quality of generic medicines, the measures that have been adopted to invariably push them and stop any advice, even, are not proportional means of achieving health objectives. Thus, in our opinion, considering the lack of infrastructure to ensure the quality of generic medicines, the measures that have been adopted to invariably push them are not proportional.
Impact on Pharmaceutical Companies and Market Dynamics
We must look at the other side of the coin as well — the pharma companies. They can also claim a right to trade through their shareholders. They can do so by alleging there is no longer a level-playing field between generic drug manufacturers and branded drug manufacturers because of the invariable push towards the former. Frankly, the argument does have weight.
A potential counterargument could be that medicine is an essential commodity. Hence, the government can regulate it with much stricter measures. Perhaps a parallel can be drawn with the educational institutes, wherein the Supreme Court is trying to balance the commercial and social nature of institutes. This again raises the broader constitutional question: to what extent can DPSPs override or dilute Fundamental Right? Does the state have carte blanche when it comes to situations like these?
For instance, the SC has held that even if selling liquor was protected, then also, the state may even prohibit liquor pursuant to the DPSPs, but that may be viewed as an utterly disproportionate measure.
Conclusion: A Call for Contextual Judicial Review
In our considered view, the key to resolving this constitutional dilemma lies in assessing the actual effect of the law on the public. A law should not be presumed reasonable merely because it purports to fulfil a DPSP. Rather, courts must assess its proportionality in light of its practical implications.
Applying this standard to the current regulations, we find that they disproportionately restrict the rights of medical professionals and patients, especially in a country lacking robust infrastructure for ensuring drug quality. Even with the withdrawal or dilution of certain provisions, the overarching point toward generic drug prescription – without the necessary safeguards – threatens both the right to health and the right to trade.
The Authors are a third year student of the Rajiv Gandhi National University of Law, Patiala and a second year student of the National Law University, Jodhpur respectively.
Image Credits: Michał Parzuchowski
Constitutional Law Society 
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