The Health Ministry on Monday conducted a meeting with Indian Medical Association (IMA) officials to discuss issues related to newly notified regulations by the National Medical Comissioner (NMC).
The NMC’s regulations, issued earlier this month, stated that all doctors must prescribe generic drugs, failing which they will be penalised, and even their license to practise may be suspended for a period.
According to a statement released by IMA on Tuesday, the medical association has requested the government to withdraw the mandatory nature of the regulation on the prescription of Generic drugs till the quality assurance of the all drugs could be ensured.
The association also urged that government to exempt Associations/Organisations from the purview of NMC Regulations and allow professional Associations to use pharma funding for CMEs and educational/research activities in a transparent and bonafide manner. Meanwhile, it also requested the government too make digitalization desirable yet optional.
“The regulation has made it mandatory for doctors to prescribe only generic drugs. It is a matter of great concern for IMA since this directly impacts patient care and safety. It is believed that less than 1 percent of the generic drugs manufactured in India are tested for quality. Patient care and safety are nonnegotiable for both, the Government and the medical profession,” according to the statement.
According to IMA, testing some samples of a batch does not provide assurance of the product quality and safety. Batch-to-batch reproducibility, and stability of the product is possible only through a comprehensively designed Quality Management System in a company complying with cGMP standards.
“The quality assurance mechanism in our country is very weak. 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 15753 drugs annually. In 2023 only around 12000 tests were conducted by CDCSO and State Drug Control Department together. If we consider one sample from each batch is tested, minimum required number of tests were around 3,00,000. India is not a signatory of the International Council for Harmonization (ICH). A new manufacturer is needed to take the approval of only the State Drug Authorities for 4 years,” IMA stated.
The doctors’ association also stated that the government should defer the enforcement of new rules till the government can assure the quality of all the drugs released into the market.
Additionally, the new regulations has also prohibited doctors from participating in seminars and conferences that have “direct or indirect sponsorships from pharmaceutical companies or the allied health sector.”
During the meeting on Monday, the representatives, National President Dr Sharad Aggarwal, HSG Dr Anilkumar J Nayak and National President-elect Dr RV Asokan, requested Mandaviya to allow the doctors to attend seminars organised by pharmaceutical companies, as these events provide “opportunities for the exchange of knowledge and productive discussions.”
According to media reports, a final decision regarding the new directives will be communicated after consultations. Meanwhile, IMA has stated that the 2-hour-long meeting was “satisfactory” and they are hoping that the Government will take a favourable decision.
Last week, a Public Interest Litigation (PIL) was filed in the Supreme Court seeking stringent disciplinary actions against registered medical practitioners who do not prescribe branded medicines to patients instead of more affordable generic drugs with the same active ingredients.