India’s health minister, Mansukh Mandaviya, announced on Tuesday that the country is demanding higher standards from small and medium-sized drugmakers in an effort to enhance product quality. This move comes after Indian-made cough syrups were linked to the tragic deaths of children in Gambia and Uzbekistan last year, tarnishing India’s reputation as the “pharmacy of the world.”
While Indian health authorities and the companies responsible for manufacturing the cough syrups have denied any wrongdoing, the government recognizes the need for self-regulation within the sector. As part of this initiative, the health minister stated that the “Schedule M” of the Drugs and Cosmetics Act, 1940, which outlines good manufacturing practices, will be made compulsory for micro, small, and medium-sized firms (MSME) in a phased manner.
Implementing these practices will not only ensure quality assurance but also help reduce the compliance burden faced by these companies. In India, small and medium-sized firms are classified as those with annual revenues ranging from 50 million rupees ($606,619) to 2.5 billion rupees ($30 million).
To further strengthen the regulation of cough syrup exports, India has tightened scrutiny since last month. It is now mandatory for companies to obtain a certificate of analysis from a government laboratory before exporting their products. In recent risk-based inspections and audits conducted by national and state drug regulators, 105 pharmaceutical companies were found to have products that did not meet the required quality standards, leading to regulatory action.
The health minister’s meeting with industry representatives follows concerns raised by Laghu Udyog Bharati, an affiliate of the Rashtriya Swayamsevak Sangh, a powerful Hindu group close to Prime Minister Narendra Modi’s political party. The group had initially called for a revision of the risk-based inspections in a letter to the health ministry, but later retracted the letter, citing an inadvertent issue.
By implementing stricter standards and regulations, India aims to restore its position as a trusted provider of high-quality pharmaceutical products to the global market.