DTAB: Study required to substitute the Prescriptions at Jan Aushadhi Stores

The proposed substitution would solely be permissible in Jan Aushadhi stores to foster the dissemination of superior quality generic medications at economical prices.

The Health Master

April 4, 2024

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DTAB Drug Technical Advisory Board — DTAB

Table of Contents

Last Updated on April 16, 2024 by The Health Master

Jan Aushadhi

The Pharmacological Technological Assessment Board (PTAB) has advocated the establishment of a subsidiary group to investigate the potentialities of authorizing substitution of prescribed medications and narcotics and psychotropic substances-based medications by Jan Aushadhi Kendra (JAK) pharmacies under Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP), to enhance the efficacy of the Jan Aushadhi Plan through the advancement of generic medications.

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The Recent Meeting Insights

The most recent assembly of the Board, which transpired recently, was contemplating certain propositions for which it had already proffered recommendations to the pertinent ministry for requisite measures, including the publication of preliminary regulations.

The Ministry apprised the Board that owing to numerous significant notifications for alterations of regulations under the Drugs and Cosmetics Act, 1940 issued subsequent to these recommendations, the PTAB recommendations ought to be meticulously reviewed and amended in light of the updated regulations and recent notifications.

The Suggested Proposal

One of the propositions entailed sanctioning JAKs to replace medications specified in Schedule H, Schedule H1, or Schedule X with medications containing identical substance, potency, and dosage form.

The proposed substitution would solely be permissible in Jan Aushadhi stores under PMBJP to foster the dissemination of superior quality generic medications at economical prices.

Further Recommendations and Amendments

Upon revisiting the proposition, the PTAB recommended the establishment of a sub-committee for exhaustive scrutiny before contemplation.

Additionally, the Board proposed the inclusion of a member from the National Medical Commission (NMC) in the sub-committee.

Rule Amendments and Observations

It is noteworthy that the Board advocated the amendment of Rule 65(11A) of the Drugs and Cosmetics Regulations, 1945 in its 81st session convened on November 29, 2018, post-deliberation.

The Rule 65(11A) stipulates that no individual dispensing a prescription containing substances enumerated in the Schedule H and Schedule H1 or X, may dispense any alternative preparation, whether comprising the same substance or not, in lieu thereof.

Consequently, the pharmacies, including the JAKs, are proscribed from substituting medications whilst dispensing prescription drugs.

The proposition posited that in order to augment the efficacy of the Jan Aushadhi Plan through the advocacy of generic medications, the Rule may be amended to solely permit the JAKs for medication substitution whilst dispensing a prescription containing substances delineated in Schedule H and Schedule H1 or Schedule X.

Observations on Rule Amendments

The PTAB, during the duration, permitted the amendment of the regulation, contending that this could facilitate the proliferation of superior quality generic medications at reasonable prices.

Government Initiatives and Expansion Plans

The Minister for Chemicals and Fertilisers and Health and Family Welfare, Dr. Mansukh Mandaviya, articulated earlier this month that the count of JAKs has been augmented from 80 in 2014 to approximately 11,000 presently, and it is estimated that 10-12 lakh individuals frequent these Centers daily.

Prime Minister Narendra Modi recently divulged intentions to broaden the geographical reach of these Centers nationwide by escalating the number of outlets to 25,000 within the ensuing two years.

The Ministry also disclosed a financial support initiative for JAKs in mid-March, through a Memorandum of Understanding between the Small Industries Development Bank of India (SIDBI) and Pharmaceuticals and Medical Devices Bureau of India (PMBI), the implementing agency of PMBJP.

Under the MoU, project loans for a credit limit of up to Rs. 2 lakh at a competitive and reasonable interest rate will be extended by SIDBI for small entrepreneurs of Jan Aushadhi Kendras, asserted the Ministry.

The Central government has made strides toward fortifying the network of JAKs in the country, elaborated Dr. Mandaviya, accentuating that extensive efforts were invested in fortifying the procurement process, broadening the assortment of products offered, maintaining a consistent supply chain network, as well as ensuring rigorous quality checks and controls.

He further underscored that the government furnished financial aid to individual operators of these JAKs, encompassing additional assistance for those situated in secluded and mountainous regions, to incentivize them to inaugurate these centers.

This, he contended, furnished small entrepreneurs with financial independence whilst concurrently bolstering the network and outreach of these Centers across the nation.

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