90% of cough syrup makers audited, ‘rot’ to be cleared by next year: CDSO

Metro India News | MUMBAI

The Central Drugs Standard Control Organisation (CDSO) has audited nearly 90 per cent of cough syrup manufacturers across India and expects to eliminate major quality concerns in the sector by next year, a top official said on Monday.

Speaking at the 11th edition of the Global Pharmaceutical Quality Summit in Mumbai, Drugs Controller General of India Sanjiv Singh Raghuvanshi said the regulator has physically inspected 1,250 manufacturing sites out of more than 1,300 units producing cough syrups in the country. The inspections were carried out under a risk-based framework, with authorities taking strict action wherever serious violations were detected.

“We practically audited more than 90 per cent of cough syrup manufacturers in this country. There are about 1,300 plus manufacturers who were manufacturing cough syrups, and till now we have audited 1,250 of them by physically going to their sites. As we do in risk-based inspection, we took serious actions on serious non-compliances,” Raghuvanshi said.

He expressed confidence that the “rot” in cough syrup manufacturing would be addressed by the next season, adding that the sector would move past recurring quality-related issues.

The official noted that both state regulators and the Central regulator are now auditing company sites under revised norms for good manufacturing practices and requirements. The implementation of the revised Rule M, which is now in force for all companies following granted extensions, is expected to have a long-term impact on the domestic pharmaceutical industry and improve the quality of medicines produced for global markets.

In the last 10 months, authorities have issued around 850 Corrective and Preventive Action (CAPA) notices to manufacturers to ensure compliance with quality standards. However, Raghuvanshi said that none of these notices have yet received a satisfactory response.

The intensified inspections and regulatory push come amid heightened scrutiny of drug quality standards, with regulators aiming to restore confidence in India’s pharmaceutical manufacturing sector.