Lessons from Maiden: Gambia deaths raise several questions

Pharma regulatory system needs re-examination. It's not just overseas buyers of Indian pharma products who are at potential risk. Counterfeit drugs remain a major threat in the domestic market

The Centre’s decision to set up a four-member committee to investigate allegations against Maiden Pharmaceuticals raises key questions about the regulatory systems that govern India’s pharmaceutical industry. An immediate probe following the death of 66 children in The Gambia after being allegedly administered paediatric cough syrups manufactured by Maiden Pharmaceuticals suggested that the company had been using contaminated raw material. Further investigation revealed that the company had not been following the Good Manufacturing Practices (GMP) prescribed under the Drugs and Cosmetic Rules. As a result of these discoveries, which have caused an international scandal with the World Health Organization (WHO) getting into the act, the full might of the powers of the Centre and state government has been brought to bear on Maiden Pharmaceuticals. All manufacturing has been halted and a show-cause notice has been issued to the company to explain multiple discrepancies linked to manufacturing and product permissions that were found by the Haryana drug authority and the Central Drugs Standard Control Organisation (CDSCO).

This flurry of investigative and proscriptive activity is only to be expected when set against the international embarrassment the incident has caused to the Indian pharma industry. India is the world’s fourth-largest producer of pharma products and one of the biggest exporters of generic drugs. According to the WHO, two toxic contaminants, diethylene glycol and ethylene glycol, were found in four cough syrups manufactured by the Delhi-headquartered company at its facility in Haryana, and they may have caused acute kidney failure in the Gambian children who died. In addition, the CDSCO probe found, among other things, that the date of manufacture printed on the drug product label (December 2021) predated the batch manufacturing date (2022). If investigation into one of Maiden’s multiple product portfolios — it also makes tablets, gels and injectables — has revealed so many transgressions, it is clear that the company has many questions to answer for its entire business. Equally, so do the state and central drug regulators.

The principal question is the robustness with which these regulators conduct their inspections. How does a company that has been around for 32 years (according to its website) and claims to be a contract-manufacturer with a global presence get away with these dangerous practices? How often do the state and central drug regulators conduct inspections? How thorough are their investigations? These questions have, in fact, been frequently asked in the past as factories of Indian drug companies far larger than that of Maiden Pharmaceuticals have failed serial US Food and Drug Administration inspections. It is not just overseas buyers of Indian pharmaceutical products who are at potential risk. Counterfeit drugs remain a major threat in the domestic market. A study by industry body Assocham shows fake drugs are a booming business in India, accounting for a shocking 25 per cent of the domestic medicine market. The study also says the Delhi-National Capital Region is the epicentre of this counterfeit business. This state of affairs could not have emerged or flourished without either the complicity or the rank inefficiency of regulatory authorities. With the eyes of the global pharma industry on it, the investigation into Maiden Pharmaceuticals will no doubt be as forensic as possible. But regulators may well benefit from a similarly thorough re-examination of their own mode of functioning.