A senior executive of a prominent lobby group said the fresh regulations were being examined. “If doctors prescribe only generic molecule names, then there may be an issue with quality. With a branded generic there comes a quality assurance and thus this is critical for patient safety,” the person said.
“There are over 10,000 manufacturers of medicines in the country, and not all of them follow the same quality guidelines. Therefore, with such a move, who takes responsibility for quality and patient safety – will the doctor be accountable?” he added.
Further, once the doctor prescribes the molecule name, the chemist will choose which brand to give the patient, said pharma industry insiders.
“Power thus shifts to chemists instead of doctors. Whichever company offers better incentives, the chemist would prefer it,” the industry feared.
The revenue of the pharma industry may decrease and this could affect research and development. And some patients might worry about the effectiveness of generic drugs, he added.
Trade margins for drugs are fixed – 10 per cent for wholesalers and 20 per cent for retailers (chemists). However, smaller companies are known to offer better margins for their medicines, which they don’t push through doctor prescriptions but through trade. These are known as trade generics. Now big pharma companies are also stepping up their game in this segment.
India is a branded generics market where companies make generic or copy-cat versions of a drug that has lost its patent, and sell them under several brand names. For example, paracetamol can have hundreds of brand names. The NMC has asked doctors not to prescribe branded generic drugs.
Industry insiders say this is a step towards implementing and codifying the Uniform Code of Pharmaceutical Marketing Practices (UCPMP).
“At the moment the UCPMP is a voluntary set of guidelines preventing pharma companies from giving freebies to doctors, but it falls upon pharma associations to enforce the code,” said a senior executive of a pharma firm.
“The regulations have asked doctors to avoid prescribing branded generic drugs, which may be less costly than the branded patent version but costlier than the generic version of the drug that is manufactured in bulk. Doctors should take it as an ethical responsibility to prescribe only those generic medicines available in the market and accessible to patients,” Bajaj added.
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