India’s apex medical regulatory authority has said it is “holding in abeyance” rules that would have required doctors to prescribe medicines only in generic or chemical names and that had drawn protests from medics.
The National Medical Commission (NMC) said on Wednesday that its Registered Medical Practitioner (Professional Conduct) Regulations 2023 notified on August 2 “shall not be operative and effective” until a further gazette notification on the subject.
The Indian Medical Association (IMA), the country’s largest body of doctors, that had complained to Union health minister Mansukh Mandaviya about the NMC rules, demanding their withdrawal, on Thursday described the NMC’s abeyance decision as a “grand victory”.
Doctors in private and government institutions as well as IMA executives had warned that the rule mandating generic names of medicines would shift the choice of the brand to pharmacists and increase patients’ risk of exposure to substandard drugs.
The IMA, in a letter sent to Mandaviya, had said less than 1 per cent of generic drugs produced in India were tested for quality. The IMA had also cited a government-appointed panel’s observations that problems in the drug regulatory system in India were primarily due to weak infrastructure, inadequate testing and drug inspection staff shortages.
“The quality assurance mechanism in our country is very weak. India has more than 300,000 batches of 70,000 drug formulations,” the IMA letter had said, also flagging concerns that current drug inspections cover only around an average 15,000 drugs annually.
The NMC panel that crafted the rules asserted that generic medicines are less expensive and would help patients save money. But IMA executives argued that the rules, appearing to be patient-friendly, had the potential to expose patients to poor quality medicines.
The IMA had also opposed other rules in the NMC’s August 2 notification that would have prohibited professional medical associations from accepting funds from pharmaceutical companies and to digitise medical records of patients within three years.
In its letter, the IMA had demanded that professional medical associations be exempted from the purview of NMC regulations which are intended for individual doctors and that such associations be allowed to use pharma funding for education and research activities “in a transparent manner”.
The IMA had argued that professional associations should be allowed to use pharmaceutical funds to organise continuing medical education programmes that help update doctors’ knowledge of advances in medicine, “as long as individual personal gains were not allowed”.