Nation-wide raid on pharma cos is part of risk-based inspections planned in December last year: CDSCO

Shardul Nautiyal, MumbaiThursday, March 30, 2023, 08:00 Hrs  [IST]

The cancellation of licenses of 18 Indian pharma companies for manufacturing spurious drugs is the outcome of the risk-based inspections planned by the Central Drugs Standard Control Organization (CDSCO) in December last year, according to senior CDSCO officials associated with the development.

The Drugs Controller General of India (DCGI) office was planning to undertake massive risk-based inspections pan-India following the World Health Organization (WHO) holding Indian pharma companies accountable for exporting contaminated medicines in the aftermath of deaths of several children in Gambia and Uzbekistan.

Around 76 pharma companies were inspected across 20 states/UTs by a joint team of the state and central licensing authorities. The CDSCO has identified around 203 pharma companies and more than 25 pharma companies have been issued show cause notices.

“Risk based inspection criteria is based on the number of sub-standard samples of the respective manufacturer found in the market in the past three years. The DCGI is going to undertake risk based inspection on a massive scale starting from Himachal Pradesh and Sikkim based on the performance and status of the states in terms of keeping a check of the substandard medicines or products in the supply chain,” according to a senior CDSCO official.

Majority of the pharma companies under government scanner are from Himachal Pradesh (70) Uttarakhand (45) and Madhya Pradesh (23), as per official sources.

According to regulatory experts, the risk-based inspections are based on the current good manufacturing practices (GMP) and good laboratory practices (GLP) under the Drugs & Cosmetics, Rules, 1945. These inspections which are conducted by the state drug licensing authorities and the DCGI audits manufacturer's compliance on sanitation, hygiene, self-inspection, quality audits, prevention of cross-contamination and bacterial contamination during production among other critical areas.

“Observations have been made by the regulatory authorities related to data integrity issues, warning letters, import bans and quality oversight not being maintained for Indian pharmaceutical companies. It is extremely important for Indian pharmaceutical companies to raise the bar as far as quality of the medicines is concerned. Getting WHO approvals is not difficult from the drug regulatory authorities in India but getting US FDA or UK MHRA approvals requires a lot of scrutiny as the norms in the regulated markets are very stringent,” according to a drug regulatory expert.