Even as the National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023, is held in abeyance till further notice, it has strengthened the call for quality medicines. Let us examine the possible impact on the pharma sector.
Speaking for most doctors, the Indian Medical Association (IMA) compared the National Medical Commission’s (NMC) push towards promotion of generics as “running trains without tracks’’, reasoning that not all generic medicines are of the same quality as their branded counterparts.
In contrast to the IMA’s stance, the Alliance of Doctors for Ethical Healthcare (ADEH) has put out a statement urging the NMC to reverse its decision to put the directive in abeyance. Their suggested solution: issue a “fresh, improved directive mandating doctors to write prescriptions in generic name only with the company name in the bracket if any RMP desires to”.
The ADEH statement points out that as generic names are used during the training of doctors in pharmacology and all clinical subjects, they should be allowed to continue to write prescriptions in generic names until the government can assure through concrete evidence that all medicines available in the market are of standard quality. In the absence of such reliable assurance, doctors have to rely on the company’s reputation, his/her individual experiences as well as of fellow doctors.
The ADEH statement also suggests that within five years, there should be a move towards a situation in which all medicines in India are of standard quality, whatever may be the manufacturing company. To monitor the progress towards this end, ADEH suggests that National Drug Surveys should be carried out based on representative samples of medicines in the retail market. Once this goal is achieved, all brand names should be gradually done away with.
They also urged the government to ban all irrational Fixed Dose Combinations (FDC) that constitute around 40 per cent of the retail market in India compared to seven per cent in World Health Organisation’s Essential Medicine List. Writing generics in prescriptions, the ADEH stated, becomes a huge challenge if irrational FDCs with multiple ingredients are to be prescribed using generic names.
What do these recommendations mean for the pharma sector in India? Spanning companies of all sizes, the sector is only as strong as its weakest link. Smaller pharma companies do not always have the finances to put quality systems in place, yet contribute to affordability and access. Should the government crack down hard on quality, most MSME pharma companies are likely to fold up. Not only will this be a loss of livelihoods, it might impact medicine prices.
A crackdown on quality seems inevitable. Even though GMP norms are officially in place, recent global criticism on pharma quality triggered by children’s deaths linked to cough syrups made in India, have shown that implementation is patchy to say the least. In early August, Union Health Minister Mansukh Mandaviya announced new timelines for adoption of GMP norms. Pharma companies with an annual turnover of over Rs 250 crore have within six months, those with a turnover of less than Rs 250 crore have six months more to adopt GMP norms, else may be penalised. Will the GMP laggards fall in line this time?
Also, pharma companies might need to lay off their armies of medical representatives (MRs) if doctors cannot prescribe brands. While some part of this salesforce might be needed to shift build rapport with the pharmacy-distributor side, it’s fair to say that the NMC regulations will change the rules of pharma marketing.
The NMC’s regulations prohibit doctors and their families from accepting gifts, fully-paid trips to medical conferences, etc. These restrictions are already part of the Uniform Code for Pharmaceuticals Marketing Practices (UCPMP) which are supposed to be followed by all pharma companies, as all major pharma associations have accepted this code. Inspite of periodic attempts to make it mandatory, the UCPMP has stayed voluntary.
Will NMC’s attempt to shift the onus on the receiver (rather than the giver) make a difference? There are already reports of doctor associations finding loopholes in the NMC’s regulations. For instance, in the case of medical conferences, the association is free to accept sponsorship from pharma companies but not individual doctors.
The NMC diktat has resurrected important debates on the loopholes in pharma manufacturing and marketing. It is high time these weak links are addressed and fixed once and for all.