Editorial: Enforce strict quality control

It is imperative that drug control organisations are constantly reinforced to act on a real-time basis to intercept defaulters

Though belated, nemesis has finally caught up with the culprit. Haryana-based Maiden Pharmaceuticals, linked to the deaths of 70 children in Gambia recently due to its contaminated cough syrups, has now been convicted in a ten-year-old case of exporting substandard medicine to Vietnam. A district court in Haryana’s Sonepat held the company and two of its directors guilty of supplying poor-quality ranitidine hydrochloride tablets under the brand name BP(Mantek-150). Ranitidine tablets are used to cure heartburn. Incidentally, it was the Consulate General of India in Vietnam that had informed the Drugs Controller General of India (DCGI) in December 2013 that Maiden Pharma was among the 46 Indian companies blacklisted by the drugs administration of Vietnam for violation of quality norms. While it is shameful that the incident dented India’s global image of being a reliable pharmaceutical hub, the case also highlights all that is flawed in an industry on which the health and lives of people are dependent. The development must serve as an opener for the authorities tasked with regulation and quality control of the pharma sector. The deaths of children in Gambia and Uzbekistan, linked to contaminated cough syrups supplied by Indian companies, have raised questions over flaws in regulatory mechanisms and quality control measures. In another recent case, a Tamil Nadu-based pharmaceutical company voluntarily recalled its eye drop from the United States after it was linked to a drug-resistant infection caused by a cluster of bacteria.

The alarming frequency with which such cases come to light points to a flourishing spurious drug trade, misuse of manufacturing facilities and lack of regulatory oversight. To keep track of the production and movement of medicines, it is imperative that drug control organisations are constantly reinforced and equipped with modern technology and skilled manpower to act on a real-time basis to intercept the defaulters. Had Maiden Pharma officials been convicted earlier and its licence cancelled, it would not have caused another major international embarrassment to the country — the death of 66 children in Gambia. In 2012, the Parliamentary Standing Committee on Health and Family Welfare came out with scathing observations on the lack of transparency in the regulator’s functioning. India’s standing as a major global player in the pharmaceutical sector has now taken a hit. Much of the criticism is directed at the regulatory system. The quality control crisis has been compounded by charges of lax, inefficient and corruption-ridden drug approval processes that do not follow the exacting international standards. Zero tolerance for violation of rules is the foundation on which the pharma sector is expected to stand. Indian drugmakers, enabled by their price competitiveness, have made a global mark, accounting for 60% of the world’s vaccines and 20% of generic medicines. And, Africa is an important market as India supplies half of its generic medicine needs.