NEW DELHI: More voices have emerged against the newly notified guidelines by National Medical Commission (NMC) that made it mandatory for doctors to prescribe only generic drugs. The Association of Healthcare Providers (AHPI), which represents the majority of healthcare providers in India, and the National Medicos Organisation, which represents both doctors and dentists, have also protested against the regulations that penalise doctors if they don’t prescribe generic medicines.
The Indian Medical Association (IMA) also wrote a letter to Union Health Minister Mansukh Mandaviya following their two-hour meeting with him on Monday. They have demanded the withdrawal of the regulations till there is quality assurance of all medicines.
It also expressed concern over the NMC regulations, which bar doctors from attending conferences sponsored by pharma companies, saying such a prohibition warrants reconsideration. It demanded associations and organisations should be exempted from the purview of NMC regulations.
In its letter to the health minister, the National Medicos Organisation suggested that the Registered Medical Practitioner (RMP) “shall not be penalised once he or she demonstrates the branded or branded generic medicine is efficacious than generic formulation.” As per the new regulations, the doctor would be penalised, including suspension of their license to practice for some time, if they don't prescribe generic drugs.
It also suggested that the chemical and fertilisers ministry may issue a separate circular for the pharma industry to produce cheaper formulations and sell all branded drugs as branded generic in the market.
Dr Girdhar Gyani, Director General, Association of Healthcare Providers (AHPI), also said that "in India, regulatory requirements for generic drugs differ from those in many other countries."
“Indian regulators do not mandate bioequivalence studies for generic drugs, which poses concerns about their quality. Generic drugs are often manufactured by numerous small companies, some of which may not adhere to rigorous quality control standards. Doctors' decision to prescribe branded or generic drugs is based on various factors, including trust in established companies and past experiences with drug quality.”
He also said the NMC regulation on barring doctors from attending medical workshops, seminars, conferences and symposia etc., may “hinder their professional progress, participation in academic/ research activities and thereby potentially denying patients the advantages of the latest medical innovations.”
Speaking with this paper, Dr Rajeev Jayadevan, past president of IMA Cochin, said that in India, there is considerable variation in quality between tablets containing the same medication made by multiple manufacturers.
“This means that not all available versions will benefit the patient equally. Besides, unlike checking for a counterfeit currency bill, there is no way a practising doctor can verify the quality of each medication. Hence they trust what has worked for their patients,” he added.
The IMA, in their letter to the minister, said, “It is a matter of great concern for IMA since this directly impacts patient care and safety. It is believed that less than 1 per cent of the generic drugs manufactured in India are tested for quality. Patient care and safety are nonnegotiable for the government and the medical profession,”.
It added that the quality assurance mechanism in our country is fragile. “India has more than 3 lakh batches of 70,000 drug formulations; the quality assurance mechanism in our country can ascertain the quality control of only 15,753 drugs annually,” it said.
“In 2023, only around 12000 tests were conducted by CDSCO and State Drug Control Department together. If we consider one sample from each batch tested, the minimum required number of tests was around 3,00,000,” the IMA said in its letter.
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