India (Common Wealth) _ The health minister said on Tuesday that India is requiring greater standards from small and medium-sized drugmakers in order to enhance product quality after Indian-made cough syrups were connected to the deaths of children overseas.
Following the deaths of at least 89 children in Gambia and Uzbekistan last year after eating cough syrup made in India, India’s image as the “pharmacy of the world,” offering cheaper alternatives to Western medicines, took a knock.
The Indian government has rejected any relation between the deaths and cough syrup made in India. The syrup manufacturers have likewise denied any involvement.
Health Minister Mansukh Mandaviya stated that self-regulation in the field was necessary, that ‘Schedule M’ of the Drugs and Cosmetics Act of 1940, which defines good manufacturing procedures, would be phased in for micro, small, and medium-sized enterprises (MSME).
“This will help in quality assurance and also reduce compliance burden,” the minister said after meeting with industry representatives.
Small and medium-sized businesses in India have yearly revenues ranging from 50 million rupees ($606,619) to 2.5 billion rupees ($30 million).
Since last month, India has increased supervision of cough syrup exports, requiring companies to get a certificate of analysis from a government laboratory before exporting products.
Following risk-based inspections and audits, the country’s national and state drug regulators took action against 105 pharmaceutical companies, he emphasized.
His discussion with industry representatives came on the heels of a unit of a strong Hindu group allied to Prime Minister Narendra Modi’s political party raising concerns about risk-based inspections.
In a letter to the health ministry, an affiliate of the Rashtriya Swayamsevak Sangh, the ideological parent of Modi’s party, urged for a rewrite of these inspections before retracting the message and claiming it was made mistakenly.
