The Ministry of Health and Family Welfare, on May 12, 2023, issued an Office Order directing heads of hospitals and polyclinics run by the Central Government, and CGHS wellness centres to ensure that all doctors (including residents) prescribe only generic medicines (“Order”). Additionally, this order contains an instruction to completely curtail the visits of medical representatives to hospital premises, with the caveat that information about new launches may be communicated by way of emails only.
On the face of it, there is little fault to be found in the Order and its dicta. In fact, it ties into the recent push to promote generic medications over expensive branded drugs. That said, it may be worthwhile to take a step back and look at the legal and policy implications of this course of action afresh, especially in light of the unintended consequences it may entail.
Generics: Need to Tread with Caution
The Government, in recent years has been aggressively pushing for the adoption of generic drugs. The Pradhan Mantri Bhartiya Janaushadhi Pariyojana is a noteworthy example of this intent. Under this scheme, outlets have been set up across the country to sell affordable generic medicines. Additionally, the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 were amended in 2016, and require every physician to “prescribe drugs with generic names…and…ensure that there is a rational prescription and use of drugs”[1].
These developments are anchored on the premise that generic drugs are, in effect, identical to their innovator brand cousins. However, this thesis, while true to a certain extent, does not take into account any externalities. For instance, generic drugs may vary from branded drugs in their quality, nature of excipients, packaging, and storage and transport conditions. All of these factors, spread over the supply chain, may add up to affect the safety and efficacy of a drug once it reaches the consumer. Precisely due to this reason and the ‘invisible hand’ of the market, certain brands have emerged to command the trust and confidence of both doctors and consumers alike. Doctors may not just feel comfortable prescribing such brands, but in many cases may even recommend them.
When viewed from the above perspective, the requirement for doctors to prescribe ‘only’ generic medicines has its own set of pitfalls. A situation where a doctor prescribes a generic drug and the said drug fails to achieve its intended effects on the patient due to quality and efficacy issues, is within the realm of possibility. Would the doctor then be hauled up to explain the rationale behind prescription of that drug and how, if the drug had worked correctly, no injury or harm would have been caused to the patient. A commandment of such nature to the doctors (prescription of only generic drugs) may also be seen as interference in their professional judgment and experience, thereby affecting treatment protocols and outcomes.
Certain restrictions are placed on pharmacists, regarding substitution of prescriptions, in terms of the Pharmacy Practice Regulations, 2015 and under the Drugs Rules, 1945[2], however, if doctors are forced to write prescriptions containing only generics, the power to choose which brand to dispense will just move to pharmacists by default. This may be problematic since doctors remain answerable and liable to their patients for all services rendered unto them.
Marketing of Drugs
The Order states that visits of medical representatives to government-run clinical establishments must be completely curtailed. While the intent of this measure has not been explicitly stated, it is easy to infer that the objective here is to eliminate the proverbial ‘pharma-doctor’ nexus. While it is nobody’s case that unethical practices related to promotion and prescription of drugs are not prevalent in the industry, the objectives of any policy structured to counter this ‘nexus’ must be weighed against its potential consequences.
The Ministry of Chemicals, as early as 2014, had published the Uniform Code of Pharmaceutical Marketing Practices (“UCPMP”). The UCPMP defines a ‘medical representative’ to mean a sales representative who calls on healthcare professionals, pharmacies, hospitals, etc., in connection with promotion of drugs[3]. The UCPMP essentially prohibits any kind of quid pro quo between doctors and pharma companies. Noteworthily, the UCPMP does not prohibit the employment of ‘medical representatives’ and instead only endeavours to regulate their activities.
The Order, on the other hand, bans the entry of ‘medical representatives’ in hospital premises. Due to this measure, doctors in Government establishments will be placed at a different footing than their peers, as they may not get information on the latest therapeutic developments in a timely manner. In any case, this restriction may, most likely not even achieve its primary objective. Doctors could, theoretically, still meet ‘medical representatives’ informally, outside the hospital premises or online.
Further, entry of any person, ‘medical representative’ or not, in a public space such as Government operated hospital, is a challenge in its own right. First, legal and constitutional validity of such a restriction is dubious. Second, its implementation can never be fool-proof, as anybody could seek a consultation with a doctor and the discussion which takes place in the consultation chamber will remain out of anybody’s immediate oversight.
Therefore, instead of adopting a strategy that will push matters into the realm of the clandestine, it would make more sense for the Government to take concrete steps not just for Government establishments, but the industry as a whole. The immediate priority must be to relook at the UCPMP, make it mandatory and make necessary changes to ensure compliance.
Substance vs Rhetoric
There has been a consistent effort on the part of the Government to promote generic medicines. The Order is just another brick in the wall of resistance against the ‘pharma-doctor’ nexus. However, as discussed above, sans a regulatory framework which ensures indisputable safety, quality and efficacy of generic drugs, the preference for branded drugs by whoever can afford them, will persist. Also, it is imprudent to paint an entire industry in a negative light when the activities being undertaken by it are technically within the bounds of law. The pharma industry must be viewed as an important stakeholder in such discussions, instead of the opponent that must be defeated. It is the enterprise, investment and appetite for risk of these companies which eventually lead to breakthroughs in the field of medicine, and their need to promote their products must be balanced against ethical and consumer needs under the aegis of a code such as the UCPMP, instead of being overlooked entirely. Only with such substantial regulations in place, can an instruction such as the Order expect to succeed. Otherwise, it will remain a paper tiger with all concerned actors finding ways to circumvent the restrictions- sometimes with a view towards to better patient services and treatment, and sometimes with the aim of unjust enrichment. For pharma companies, it may make sense to explore other marketing media to educate doctors about their products, especially through the digital space.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] Para 1.5 of the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002.
[2] Rule 65 of the Drugs Rules, 1945
[3] Para 4.1 of the UCPMP.
