A pharmaceutical industry body has warned that a proposal to allow select government drug stores to substitute medications with other products that contain the same substance, strength and dose would be “detrimental” to patients.
The Indian Pharmaceutical Alliance (IPA) — an association of 23 research-based drugmakers — has opposed the proposal to allow the substitution of medicines at the Jan Aushadhi Stores — a network of 10,600 outlets that provide inexpensive generic medicines.
A technical advisory panel to the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory authority, had earlier this year recommended the constitution of a subcommittee for a “detailed deliberation” of its 2018 proposal to allow Jan Aushadhi stores to substitute drugs.
The IPA has said any rule change to allow Jan Aushadhi stores to substitute drugs might lead to similar requests from other trade channel partners — implying other chemists’ outlets — which, it said, “will not be in the interest of patients.”
Such changes could expose patients to poor quality drugs in the absence of proper drug regulatory oversight, the IPA said in a note sent to the Union health ministry. The IPA has also flagged the CDSCO’s own data indicating the presence of poor-quality drugs in the market.
Central and state drug inspectors routinely test samples of drugs to determine whether they meet quality standards. The IPA, citing the CDSCO data, said of the 7,500 samples tested over the past six months, 284 were found “not of standard quality”, 91 per cent from Category C companies.
Category C includes drugmakers with global manufacturing revenues below ₹500 crore and those registered as micro, small and medium enterprises. Industry executives say Category C companies are a major source of generic drugs in the country.
The IPA has also voiced concerns expressed earlier by the Indian Medical Association, the country’s largest association of doctors, that allowing drug substitution would shift the responsibility of what drug a patient gets from doctors to the drug store staff.
The drug store operators “may dispense drugs with a higher profit margin, regardless of the drug’s quality”, which could result in patients receiving poor quality generic drugs, the IPA said.
The IPA has also referred to existing rules that allow a new manufacturer to produce drugs that have already been in the market for four years with only manufacturing approval from state regulators and without a licence from the CDSCO. “This gives room for many substandard products in the market,” the IPA has said.
A nationwide group of patients’ rights advocates, however, has asked the Union health ministry to proceed with the proposal to allow substitution of drugs in Jan Aushadhi stores, “provided” it also acts to reduce the proportion of poor quality medicines in India to “zero”.
The IPA’s note seeks to perpetuate the myth that medicines that fail quality tests are made only by small companies, the All India Drug Action Network (AIDAN), a group of physicians, public health experts, and patients’ rights activists, has said.
But AIDAN’s demand for allowing Jan Aushadhi stores to substitute medicines is nuanced, also emphasising the need to improve state drug regulatory processes to minimise the proportions of medicines that fail in quality tests.
The drug substitution “would be in the interest of patients, provided there is an equally emphatic demand from society at large and experts” that the functioning of state drug regulators should be “radically improved”, AIDAN said.
