Prescribe, formulate a drug recall law

More than anything that goes into our bodies, medicines are arguably what most people innately trust the most. Beyond reading the expiry date and composition of pills and syrups, few worry about whether a pharmaceutical company has followed good manufacturing practices (GMPs) – which mandates testing of all excipients (everything other than the active pharmaceutical ingredients, or APIs) used in the manufacturing process – or not. That is because drug controllers, both under the Central Drugs Standard Control Organisation (CDSCO) and in each state, ensure GMPs are maintained. When this quality control system is found to be flouted, batches are seized and recalled. If the fault lies in a particular ingredient, the company supplying the substance is traced and possible sales of it to other pharma companies are traced. This is what is supposed to happen, according to CDSCO guidelines, when bad medicine is found in the market.

Remarkably, though, India is yet to have a medicine recall law. While the draft of the New Drugs, Medical Devices and Cosmetics Bill 2022, tabled by the health ministry in July and set to the replace the Drugs and Cosmetics Act 1940, mentions the recall procedure of Ayurvedic, homoeopathic, etc, medicines, it is silent on the matter of withdrawing allopathic drugs. It is not just accusations such as the latest one made by Uzbekistan – that GoI has rightly said it will look into before responding – that dent the country’s well-earned reputation as ‘pharmacy of the world’. It is also about protecting our own citizenry.

India must quickly formulate a law backed by Parliament for recalling medicines that are found to flout GMPs or contain adulterated active ingredients. Both the health and reputation of India must be safe.