ima: Revoke ‘generics only’ prescription regulation, IMA writes to minister

The Indian Medical Association (IMA) has urged the government to withdraw the regulation that mandates doctors to prescribe generic medicines, saying it should not be enforced till there is assurance that the medicines meet quality standards.

In a letter to the health minister on Tuesday, the association also asked the government to allow professional associations to use pharma funding for continuing medical education (CME) sessions (CMEs) and educational/research activities in a transparent and bonafide manner, and to make digitalisation desirable yet optional. A day earlier, health minister Mansukh Mandaviya had called a meeting to discuss issues related to the newly notified regulations by the National Medical Council (NMC).

The NMC’s regulations, issued earlier this month, stated that all doctors must prescribe generic drugs, failing which they face a penalty, including suspension of their practice licence.

The IMA’s letter said it is a “matter of great concern” since prescribing only generic drugs directly impacts patient care and safety. “It is believed that less than 1% of the generic drugs manufactured in India are tested for quality. Patient care and safety are non- negotiable for both, the government and the medical profession,” it said in the letter.
Citing the Mashelkar Report of 2003, it went on to say that the problems in the regulatory system in the country were primarily due to inadequate or weak drug control infrastructure at the state and central levels, inadequate testing facilities, shortage of drug inspectors, non-uniformity of enforcement, lack of specially trained cadres for specific regulatory areas, and the non-existence of a data bank.The IMA pointed out that currently only a few categories need BA/BE study and that all generics may not be bioequivalent.”It is worthwhile to mention here that testing some samples of a batch does not provide assurance of the product quality and safety,” the letter said. “Batch to batch reproducibility, stability of the product is possible only through a comprehensively designed quality management system in a company complying with cGMP standards.”