Coming Soon: Pharmacists may be allowed to substitute branded drugs with generics
The code of ethics issued by MCI calls for doctors to prescribe drugs by their generic name, however, due to lack of substitution law, pharmacists in the country are not permitted from judicial perspective to substitute branded medicine to their generic equivalents.
New Delhi: In a major relief, pharmacists may be soon able to substitute doctor prescribed branded drugs with generic drugs. As per recent media reports, the Prime Minister’s office has directed the Drug Technical Advisory Board (DTAB) to move amendments to the Drugs and Cosmetics Act, 1945 regarding the same.
“Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”
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However, the notification is yet to see full enforcement at the end of doctors in the country. To add to the problem, due to lack of substitution law, pharmacists in the country are not permitted from legal perspective to substitute branded medicine to their generic equivalents.
Asking for the substitution law, a letter was written to the Prime Minister (PM), Narendra Modi by the U.S. based Indian Physician, Dr Bharat Bhushan. In August 2018, Bhushan asked the PM to bring in ‘Generic Medicine Substitution Law’, the dearth of which barres proper implementation, viability and sustainability of any public health scheme in the long run.
Dr Bhushan’s letter quotes, "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.”
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Taking up the issue, the PMO has forwarded the issue to be taken up by the DTAB.
Commenting on the matter, Dr Reddy, DCGI told DNA,” 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."
Following the administrative suggestions, Dr Eswara Reddy, Drug Controller General of India gave confirmation, stating that in the preliminary stage only the Jan Aushadhi Kendras will be implementing the law.
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