The recent deaths of nearly 70 children in The Gambia due to the consumption of cough syrups made in India laid bare the systemic shortcomings of the sector. Drug regulation in India is a topic that isn’t written about often. It is a Pandora’s box left untouched as there are few other areas that display the incompetence of a system towards its citizens. The recent deaths of close to 70 children in The Gambia due to the consumption of cough syrups made in India laid bare the systemic shortcomings of the sector once again. “The state drug controller had given licences to the company only for export of these four drugs,” India’s Health Ministry had stated. But what about lapses in India? In 2013, the Tamil Nadu Drug Control Administration, in a random drug inspection of Glipizide (a drug used to treat Type-2 diabetes), manufactured by Alfred Berg & Co Pvt Ltd, found that the tablet contained not Glipizide but Glibenclamide, a different drug. Though also used to treat Type-2 diabetes, Glibenclamide has a different metabolization rate which could lead to dangerous hypoglycemia. Upon visiting the manufacturing facility, authorities found that there was no quality assurance department, as required by law. They also found that the facility did not maintain quality control records. They could not even show the register of raw materials or packing. Glibenclamide is almost five times cheaper to manufacture than Glipizide. A case was filed in the local court against Alfred Berg & Co Pvt Ltd under the Drugs and Cosmetics Act 1940, which carries a maximum penalty of life imprisonment along with huge fines. But the case has been languishing in court since 2014. This instance, recorded in Dinesh Thakur and Prashant Reddy’s recent book – The Truth Pill – is one of the many controversies that have plagued India’s drug and pharma sector. AYUSH Drug Regulation The drug regulation situation is even worse in the massive AYUSH drug market in India. For instance, Giloy (T. cordifolia) is a herb endorsed by the AYUSH Ministry. A review article by researchers of NISER, Bhubaneswar, claimed that the herb has anti-diabetic, anti-periodic, antispasmodic, anti-inflammatory, anti-arthritic, anti-oxidant, anti-allergic, anti-stress, anti-leprotic, anti-cancer, anti-malarial, anti-HIV, hepatoprotective, immunomodulatory and anti-neoplastic activities. The claim of a single drug aiming to tackle multiple ailments has naturally led to several doubts being raised. For instance, Kulkarni et al, in their multi-centre nation-wide study of giloy-induced liver injury, found “acute worsening of chronic liver disease or acute liver failure” among 43 patients who had consumed giloy. As such, Giloy has no proven benefits but there is preliminary evidence that it is causing liver injury. Shortcomings in India’s drug regulation ecosystem have come to light time and again. Recent revelations about dicrepancies in the trial numbers of Covaxin by Bharat Bio- tech has widened the trust gap. The authorities must act.
27 Oct 2022
Soham Shah
