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Coming Soon: Pharmacists may be allowed to substitute branded drugs with generics


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.

The move will apparently provide relief to patients, apart from pharmacists as generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original drug. In other words, their pharmacological effects are exactly the same as those of their brand-name counterparts.
Moreover, generic drugs are often substantially cheaper than the brand-name versions, which make it affordable for needy patients. As a matter of fact,  generic drugs are only cheaper because the manufacturers have not had the expenses of developing and marketing a new drug.
Seeing the benefit of generic drugs, the Medical Council of India in 2016 had come out with a Gazette notification, asking its doctor members to prescribe generic medicine

“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”

Read Also: Not Prescribing Generic Drugs will invite Disciplinary Action: Maharashtra Medical Council tells Doctors

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.”

Also Read: PMBJPs generic drugs up to 96 per cent cheaper than branded equivalents

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.

Also Read: Incorrect Brand: Chemist slapped of Rs 1.15 lakh for providing alternative to prescribed drug

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Source: With inputs
3 comment(s) on Coming Soon: Pharmacists may be allowed to substitute branded drugs with generics

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  1. Now one more brainwave god know whose?!!. first of all govt permits pharma companies to monopolise a particular formulation without enforcing the existing regulation to limit profit to 16% of the manufacturing cost and without defining what kind of expenditure could be counted under manufacturing cost, then permit multiple phama companies to produce the same formulations and encourage these pharma companies to actively promote their product, even by bribing the medical profession, penalise the medical profession under the guise of ethics for accepting commission from pharma companies, instead of controlling the price of branded drugs, force the medical profession to prescribe generics and penalising them when they donot prescribe generics without even defining what is generic , failing miserably in preventing production and sale of fake drugs either generic or branded, Not able to control and ensure quality and price of generic drugs, and making it a cake walk for fake drugs to be peddled under the name of generics, Now this new issue of pharmacist changing doctors prescription because in america it is permitted by law!!!. How many street side medical stores are run by pharmacist in India? in india do we have the same vigilance against the fake drugs like in america? ! in america do they have the same legislation for drugs and cometics, and same legislation to cover a petty trader and physician? Why not have good price control and mechanism to catch and penalise fake drug peddlers, and why not enforce that all the medical stores should be run by pharmacists only?? Why not ensure that all the population is covered by medical insurance. instead of demanding uncompensated service from doctors, and forcing doctors to prescribe cheap drugs? This is \” divide and rule policy a legacy of British raj where the person who has the responsibility to prescribe the drug to cure the patient does not have authority to choose the drug and a pharmacist who has no responsibility to cure the patient has all the authority in the world to chose the drug which is most profitable to him.

  2. Now one more brainwave god know whose?!!. first of all govt permits pharma companies to monopolise a particular formulation without enforcing the existing regulation to limit profit to 16% of the manufacturing cost and without defining what kind of expenditure could be counted under manufacturing cost, then permit multiple phama companies to produce the same formulations and encourage these pharma companies to actively promote their product, even by bribing the medical profession, penalise the medical profession under the guise of ethics for accepting commission from pharma companies, instead of controlling the price of branded drugs, force the medical profession to prescribe generics and penalising them when they donot prescribe generics without even defining what is generic , failing miserably in preventing production and sale of fake drugs either generic or branded, Not able to control and ensure quality and price of generic drugs, and making it a cake walk for fake drugs to be peddled under the name of generics, Now this new issue of pharmacist changing doctors prescription because in america it is permitted by law!!!. How many street side medical stores are run by pharmacist in India? in india do we have the same vigilance against the fake drugs like in america? ! in america do they have the same legislation for drugs and cometics, and same legislation to cover a petty trader and physician? Why not have good price control and mechanism to catch and penalise fake drug peddlers, and why not enforce that all the medical stores should be run by pharmacists only?? Why not ensure that all the population is covered by medical insurance. instead of demanding uncompensated service from doctors, and forcing doctors to prescribe cheap drugs? This is \” divide and rule policy a legacy of British raj where the person who has the responsibility to prescribe the drug to cure the patient does not have authority to choose the drug and a pharmacist who has no responsibility to cure the patient has all the authority in the world to chose the drug which is most profitable to him.

  3. user
    jitendra nakum March 8, 2019, 9:42 am

    what will be the benefit to patients, doctors and pharmacist ?