CDSCO

The Ministry of Health and Family Welfare has introduced comprehensive regulations for medical devices aimed at aligning the country's regulatory framework with globally accepted standards. This initiative seeks to foster a regulatory ecosystem that promotes growth and innovation in the medical device sector.

CDSCO reported top brands of paracetamol, pantoprazole, amoxicillin and other amongst failed samples reported by CDSCO. These samples are reported to be not of standard quality. Total 59 different brands from well known pharmaceutical industries failed to compile with standard quality.

Top brands like Clavam 625, Mexclav 625, Shelcal, Pan D failed various assays and quality tests, which were collected and tested by different Drugs Testing Laboratories.

CDSCO releases regulatory guidelines for sampling of drugs, cosmetics & medical devices by drugs inspectors of central & state drug authorities. As per CDSCO, it will streamline and rationalize the sampling procedure of drugs, cosmetics & medical devices and maintain a centralized monthly database of Not of standard Quality (NSQ) or Spurious drugs to publish on CDSCO.

The Central Drugs Standard Control Organisation under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices,four sub zonal offices,thirteen Port offices and seven laboratories spread across the country.

Post : Professional Consultant

CDSCO recommends widely used anti-cold syrup not to be used in children below 4 years of age, after recommendation from SEC.

The FDC of Chlorpheniramine Maleate and Phenylephrine HCl was declared as rational by Prof. Kokate committee and based on the recommendation of the committee, this office has issued NOC for continued manufacturing and marketing of subject FDC on 17.07.2015 under the 18 months policy decision.