A new blot on Indian pharma

THE spate of deaths of children, caused by the consumption of cough syrups adulterated with a toxic industrial chemical, has brought the focus back on India’s dysfunctional drug regulation system. In recent years, several such tragic incidents have occurred in India and abroad, involving drugs manufactured in this country.

Our response is the same every time — deaths blamed on contaminated or substandard drugs, inquiries by state and Central governments, raids on some manufacturing units here and there, reporting of non-compliance of norms, suspension of manufacturing licences of some units, a directive from the health ministry to states to implement regulatory norms ‘strictly’ and a return to ‘business as usual’ in no time. No heads roll, no changes are made in the regulation, vacancies in drug regulatory bodies are not filled, no errant units are shut permanently, and nobody bothers to share findings of probes ordered into earlier episodes.

The culprits that make cough syrups toxic are well known by now: diethylene glycol (DEG) and ethylene glycol. Toxic effects of the two contaminants include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, which may lead to death. Apparently, the two chemicals get mistakenly used while manufacturing cough syrups, especially in syrups that use agents like propylene glycol and polyethylene glycol. After dozens of children died in The Gambia, Uzbekistan, Cameroon, Iraq and other countries after consuming ‘made in India’ products, the World Health Organisation (WHO) has been warning national regulatory and health authorities to notify if such products were detected in their respective countries. The agency has advised national authorities to test raw materials for the presence of DEG before use in medicines. DEG is responsible for the cough syrup deaths in Chhindwara, Madhya Pradesh.

It is pathetic that cough syrup manufacturers are so careless that their products get contaminated with deadly toxins. It only goes to show that they are not adhering to mandatory Good Manufacturing Practices (GMP) rules. Are they not following GMP, or is the government giving them a long rope? It is both.

After every death due to contaminated drugs, there is talk of implementing GMP or making them stricter. The moment this is done, industry associations representing small and medium drug manufacturers seek time to implement GMP rules or seek relaxations, citing the excuse that they do not have the capacity to implement the norms. The government, too, is sympathetic, as strict implementation or closure of non-compliant units could hurt its 'Make in India' programme. After the deaths of 68 children in The Gambia, Indian agencies even accused the WHO of not following procedures and saw a conspiracy to defame Indian exports.

After the Chhindwara incident, the Drug Controller General of India has reiterated the need for drug manufacturers to comply with the Revised Schedule M of GMP. As per an official press release, he has noted that “certain firms which applied for the government’s infrastructure upgradation scheme have been given an extension till December 2025” and urged states to strictly implement the revised GMP norms. It implies that as of now, the new schedule of GMP is not being implemented.

The new schedule was introduced after an international uproar over deaths caused by India-made cough syrups in several countries. It became effective for large firms in June 2024, but small and medium-sized manufacturers (having a turnover of less than Rs 250 crore) were given time till December 2025, although most of the contaminated drugs were produced by such firms. The turnover limit was fixed in such a way as to cover a bulk of the manufacturers. Schedule M requires drug manufacturers to adhere to practices such as the Pharmaceutical Quality System, quality risk management and computerised storage systems.

A review of product quality is required, involving the analysis of data from batch records and critical process parameters. Manufacturers must retain samples of intermediate and final products for potential retesting.

So, norms are there, they are revised to make them more stringent, but there is no will to implement them. Central and state drug control authorities, tasked with enforcing the norms, are short of staff or are kept deliberately understaffed. An umpteen number of expert panels, review committees and parliamentary panels have pointed this out in the past two decades, but the situation on the ground remains unchanged. Things are especially bad in states like Telangana, Maharashtra, Tamil Nadu and Himachal Pradesh, which have a huge concentration of drug manufacturing units.

Drug regulation in India needs a fundamental change. The focus of drug regulatory authorities and the government is on the drug and pharmaceutical industry and not on consumer or patient interest. Norms are allowed to be lax, or non-compliance is tolerated to protect the industry. Otherwise, there is no reason DEG should have killed Indian children after the chemical was found responsible for the deaths of kids in The Gambia and other countries exporting cough syrups made in India. There should have been a nationwide crackdown on all manufacturers of cough syrups, and those found using DEG should have been identified and punished. All this did not happen, resulting in the Chhindwara deaths.

The 59th report of the Parliamentary Committee on Health and Family Welfare, presented in Parliament in 2012, had stated that “most of the ills besetting the system of drug regulation in India are mainly due to the skewed priorities and perceptions of the drug regulator. For decades together, it has been giving primacy to the propagation and facilitation of the drugs industry, due to which, unfortunately, the interest of the biggest stakeholder, i.e. the consumer, has never been ensured.”

The panel recommended that the mission statement of the Central drug organisation should state that it was solely meant for public health. The statement was changed, but it has remained a cosmetic change, going by the recurring incidents of substandard and adulterated drugs killing people and industry interests taking precedence over people’s health.

Dinesh C Sharma is an award-winning journalist, science commentator and author. His X handle is @dineshcsharma