A recent recommendation to allow Jan Aushadhi stores to replace a prescription medicine with a substitute has become a bone of contention between representatives from the pharmaceutical industry and health advocacy organisations.

In an open letter to the Union Health Minister, the All India Drug Action Network (Aidan) has opposed a submission from the Indian Pharmaceutical Alliance (IPA), that had said, “If the above recommendation of substituting Schedule H and X drugs is accepted for Jan Aushadhi stores, a similar request may be requested by other trade channel members. This will not be in the interest of patients”.

In its submission to the Drugs Controller General of India (DCGI), the IPA refers to the 90th DTAB (Drugs Technical Advisory Board) meeting and the discussion on amending “rule 65(11A) of the Drugs and Cosmetic Rules 1945 to allow the substitution of drugs specified in Schedule H, H1 and X with drugs containing the same substance strength and dosage form only in Jan Aushadhi stores …. for promotion of quality generic medicines at affordable prices”.   The DTAB deliberated and recommended that a sub-committee may be constituted for further detailed deliberation before consideration, the IPA noted.

Aidan countered IPA’s view, saying the recommendation would be “in the interest of patients”, provided there is a demand from the society and experts and “that the functioning of the state FDAs (Food and Drug Administration) should be radically improved with quantum jump in the number of drug inspectors as per the Mashelkar Committee report along with full transparency and accountability in the FDAs’ functioning resulting in reducing the proportion of Not Standard Quality (NSQ) medicines in India to zero. Once this is done, we can move towards achieving the goal of eliminating all brand names as suggested by the renowned Hathi Committee way back in 1975.” 

The IPA represents major domestic drugmakers and Aidan is a network of health organisations campaigning for the rational use of medicines and availability of essential medicines. The Centre’s Jan Aushadhi stores sell medicines at reduced prices.  Generic names mention the chemical ingredient of the drug, not brand names. Industry representatives had opposed earlier moves for all prescriptions to mention only generic names, fearing it would shift decision-making from doctors to the retail trade.


IPA said, the current regulatory ecosystem was evolving and “permitting generic substitution may have adverse implications for patient care. As many as 7,500 samples were tested for the last 6 months out of which 284 were declared NSQ, 91 per cent from Category C Companies (CDSCO data 2023).”  Further, in a recent quality drive by the Centre, around 137 facilities were inspected, show cause notices were issued to 73 firms and they cancelled licenses of about 50 companies.

“For chronic ailments, different generics products from the companies will have an impact on outcomes; Channel partners may dispense drugs with a higher profit margin, regardless of the drug’s quality. This can result in spurious generic drugs being dispensed putting patient care and human life at risk,” IPA said.

Aidan, however, countered, “IPA’s statement perpetuates the myth that NSQ medicines are made only by small companies. It overlooks the fact that the National Drug Survey has shown that many of the renowned brands have also been found to be NSQ.“

Quality standardisation

IPA pointed out that “a significant proportion of products are not included in Indian pharmacopoeia, which provides an important foundation for ensuring quality standardisation for manufacturers. Investments are made by branded businesses/companies through BE (bio-equivalence) and CT (clinical trials) to bring these medicines to market to meet patient needs.”

Presently, a new manufacturer does not require a DCGI license/ approval for manufacturing a drug which has been in the market for over four years. A State Drug Authority approval for manufacturing is all it required, and “this gives room for many sub-standard products in the market,” IPA said, urging the Centre to not pursue the DTAB recommendation.  

Aidan, however, urged the Centre to go with the recommendation and set up an expert panel to assess the feasibility of allowing generic substitutions for these prescription drugs.