Pharmacists can substitute branded drugs with generics

Prime Minister’s office has asked the Drug Technical Advisory Board (DTAB) to move amendments to the Drugs & Cosmetics Act, 1945 that will allow pharmacists to substitute doctor’s prescription of branded drugs with generic medicines. Following suggestions, the Drug Controller General of India confirmed that in the initial phase, only the Jan Aushadhi Kendras will be implementing the law.

“DTAB has written to the Minister of Health, recommending implementing the generic medicine substitution law. This will be implemented only in the Jan Aushadhi Kendras for now,” said Dr Eswara Reddy, Drug Controller General of India.

Dr Bharat Bhushan, a US-based Indian physician, had written to Prime Minister Narendra Modi in August last year, asking him to bring in the ‘Generic Medicine Substitution Law’, the lack of which is a barrier in proper implementation and long-term viability and sustainability of any public-health scheme.

“In the USA and Europe, the laws legally authorise pharmacists to substitute branded medications with the generic equivalents. Whereas Rule 65 (11 A) of Drugs & Cosmetics Rules, 1945 states that no person dispensing a prescription containing substances specified in Schedule H, H1, or Schedule X may supply any other preparation whether containing same substances or not in lieu thereof. We need to omit the said rule to achieve viability,” Dr Bhushan wrote in his letter.

While the law will soon be implemented in Jan Aushadhi Kendras, it may not see the light of the day at other pharmacies due to the ethics code issued by the Medical Council of India (MCI). Additionally, it is believed the pharmacists will push those brands that offer higher margins.

Though the code of ethics issued by MCI calls for doctors to prescribe drugs by their generic name only, due to lack of substitution law, pharmacist in the country are not legally authorised to substitute branded medicine to their generic equivalents.