Chemists’ association demands action against spurious, substandard drugs
These spurious drugs are primarily supplied from states like Delhi, Himachal Pradesh, Uttarakhand and Hyderabad where the enforcement of FDA regulations is lax, as per the association
The Chemists’ Association Pune District (CAPD) has claimed that as much as 20% of medicines in the market may be counterfeit and of low quality, and has written to the Food and Drug Administration (FDA) demanding mandatory reporting of third-party drug manufacturing and action against spurious and substandard drugs among others.
According to the CAPD, the spurious and substandard drugs include common medications such as antacids, Cancer treatments, and antipyretics among others. These spurious drugs are primarily supplied from states like Delhi, Himachal Pradesh (HP), Uttarakhand and Hyderabad where the enforcement of FDA regulations is lax, as per the association.
CAPD has written to the FDA saying: “There is growing concern about spurious drugs circulating within the state market and a need for stringent regulatory measures to safeguard public health. Making it compulsory for all pharmaceutical companies to report their third-party manufacturing arrangements can serve as a vital step in addressing this issue. The problem of counterfeit and spurious drugs has posed serious threats to patients, healthcare systems, and regulatory authorities. The lack of transparency around third-party manufacturing agreements often allows loopholes that these harmful products can exploit.”
Vivek Tapkir, vice-president, CAPD, said, “As per government rules, the discount margin is 20% for wholesalers and 10% for retailers and no one can sell genuine medicines at a discount more than this. However, counterfeit drugs are being sold at much higher discounts.”
As per the CAPD, the Maharashtra FDA has instructed distributors, wholesalers, and retailers to report any drugs purchased from other states but compliance remains minimal with few people reporting the details of drugs imported from other states. While the state FDA is intensifying efforts to crack down on the sale of spurious and substandard drugs, stricter enforcement measures are urgently needed, according to the association.
“Many of these counterfeit and substandard drugs are LASA (lookalike, soundalike) medicines which often contain large amounts of binders and excipients, posing serious health risks to the public. It should be mandatory for all pharmaceutical companies to report and disclose the details of third-party manufacturers responsible for producing their drugs. This would enhance transparency across the supply chain and make it easier for the FDA to track drug quality and origin,” said Tapkir.
Girish Hukare, joint commissioner, FDA (drugs), Pune region, said, “Mostly, the spurious drugs are made of a known brand which makes them easy to be sold in a short time. Unless citizens come and complain to the FDA, it is difficult to find which drugs are spurious or substandard. Citizens fall prey to such drugs due to huge discounts. If such counterfeits are in large quantities, they get caught easily. However, if the quantity of such drugs available in the market is less, it becomes difficult to catch them.”
Hukare further claimed that the percentage of spurious and substandard drugs in the city is not around 20% and is likely to be much less. “Even if the drugs are manufactured in other states, the central drug authorities have strict vigilance across the country. We get details about the narcotic drugs and psychotropic substances among other drugs supplied in the state. However, practically all drugs cannot be tested and are not expected to be tested for quality check,” he said.
The CAPD has also demanded that regular inspections and audits of third-party manufacturers be conducted, both domestically and internationally, to ensure compliance with FDA standards. Besides, a publicly accessible database listing pharmaceutical companies and their third-party manufacturers can serve as a resource for healthcare professionals and consumers to make informed decisions about drug safety and quality. The association has also demanded stern action against pharmaceutical companies that fail to comply with the mandatory reporting requirements or are found guilty of introducing spurious drugs into the market.