Following allegations that cough syrups manufactured in India were linked to deaths in other countries, the Ministry of Health and Family Welfare (MoHFW) may soon notify proposed rule changes to make good manufacturing practise (GMP) mandatory for all pharmaceutical firms, according to a Mint report.

The Centre recently made GMP mandatory for micro, small, and medium-sized drug manufacturing businesses. Only 2,000 of the country's 10,500 manufacturing units have GMP certification from the World Health Organisation. GMP establishes essential standards for improving product quality through control measures involving materials, methods, machinery, and processes.

Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), recently met with drug manufacturers and industry stakeholders. Meetings with state drug controllers are also being held to raise awareness about enforcing the new GMP regime.

The lack of consistency in existing regulations has resulted in inconsistent enforcement and a lack of testing infrastructure. Over 100,000 drug samples are tested in India each year, but a lack of coordination between states and the central government can lead to delays in investigations and subsequent actions.

According to one of the state drug controllers, pharma companies have several questions about how to implement the new changes.