August proved a troubling month for patient safety — with at least four separate reports related to fake medicines, voluntarily recalls and alleged misbranding.An inter-State fake drugs network was busted after counterfeit blood pressure drug (Nicardia Retard) was seized in Gujarat by the Ahmedabad Crime Branch and State Food and Drugs Administration (FDA). The fakes were reportedly flagged by JB Chemicals after products carrying its branding but not made by it were found in the market.In the second instance, the Drug Controller General of India flagged a fake rabies vaccine batch carrying the same branding and batch number as an Indian Immunological’s vaccine. A search at a Delhi residence by the Crime Branch and drug inspectors found “rabies vaccine (Abhayrab); Batch No. KE25012… misbranded (not manufactured by Indian Immunologicals Ltd)”, said a public notice from the regulator.The third report was on the voluntary withdrawal of 11 eye drops by Sun Pharma as a “precautionary” measure. And the fourth was about the cancellation of Cipla’s Pune warehouse licence, and its subsequent restoration by the Maharashtra FDA following a court directive, after Cipla contested the cancellation. It involved an ongoing case over alleged misbranding of Reactin Plus tablets, the State FDA said.The frequency of these alleged violations poses critical questions on patient safety: Are fake or ineffective medicines withdrawn from the market before they are consumed by patients? Does the drug regulatory framework need tightening or are more cases being reported due to improved regulatory intervention? The Health Ministry, for example, regularly releases reports of ‘not of standard quality’ (NSQ) medicines and spurious drugs (imitation products that may or may not have the active ingredient). The spurious drug alert, though, does not name the company or brand, except to say it is being investigated.Health threatThe July NSQ/spurious drug report, for example, mentions spurious buprenorphine injection IP 2ml, a painkiller. In the Ahmedabad case involving fake blood pressure medicines, media reports said 1,500 strips (of 10 tablets each) may have been sold to patients.Dr Abhay Shukla, National Co-convener of Jan Swasthya Abhiyan, explained that medicines are prescribed to treat a particular condition. So if a medicine is NSQ, it could be “health-threatening”, if not life-threatening. An ineffective NSQ blood pressure medicine could lead to a stroke or heart attack, he pointed out.Dr HG Koshia, former Commissioner of the Gujarat Food and Drugs Control Administration, recollected that when he took charge (2009-10), about 95 per cent of recalled drugs had been consumed before the companies began recalling them. The State regulator then put in place an SMS-based recall system to alert the supply chain, distributor, wholesaler and retail chemist, said Koshia, who retired in 2025.Who is responsible?Company representatives sometimes claim that they have visibility only up to the distributor and not the neighbourhood chemist. That is not a legitimate reason, said Koshia, since manufacturing licences are for selling quality medicines, and the onus is on them to produce medicine that retains quality until expiry.If there is a recall for some reason, the companies must ensure the products come back to them, he said, adding that distributors have the supply data for the medicines. The Drugs and Cosmetics (D&C) Act mandates a bill or memo for every product sold, mentioning the product name, batch number, the names of purchaser and wholesaler, the quantity sold and the expiry date. This has been “the law of the land since 1945”, he said.Former Commissioner of Maharashtra Food and Drug Administration Mahesh Zagade said the regulatory framework for medicines is adequate.It is the Health Secretaries and drug regulators who have to implement the food and drugs statutes and act against those failing to do their job, he said.Zagade had, as FDA chief, called for compensation for patients when J&J recalled hip implants. On product recalls, he said there are provisions to detail the drug supply chain down to the consumer “but they are on paper”. Almost 100 per cent of recalled products get consumed, he alleged, with the reasons ranging from delays in sample testing to corrupt “money-making”.Fixing accountabilityManufacturers are mandated to test raw materials before using them and the finished product before releasing it in the market, Zagade said, a process that can ensure only quality products are available.Parliamentarians also need to ensure that laws they help formulate are implemented in their constituencies. Otherwise they should raise it with the Central and State governments, he said, adding that this culture of holding people accountable would help protect customer rights.Published on September 7, 2026