Gujarat FDCA Cancels Licenses Of 2 Pharma Companies Based On Risk-Based Inspections

Mumbai : The Gujarat Food and Drug Control Administration (FDCA) has cancelled manufacturing licenses of 2 pharma companies based on risk-based inspections of 5 companies due to non-compliance to GMP norms and quality.

The state drug regulator also canceled the license of one of the sections of a company that produced products which were unstable and multiple failures happened during quality testing and analysis.

“Licenses were canceled because these companies could not produce the stability data as per the norms. We had to take the urgent decision to cancel licenses in the interest of public health,” informed Gujarat FDCA Commissioner Dr H G Koshia.

The Gujarat FDCA had earlier cancelled 15 product licenses of 6 pharma companies based on risk-based inspections. In these risk-based inspections, it was revealed that the products of some of the companies, producing widely prescribed gastrointestinal medicines and vitamins, were not-of-standard quality (NSQ). Products also include oral rehydration salt (ORS) and medicines like azithromycin for cold and amoxicillin for bacterial infections and also antimalarial medicines.

These risk based inspections are being done pan – India. NSQ medicines were also reported earlier this year from Uttrakhand, Himachal Pradesh (HP), Madhya Pradesh (MP), Andhra Pradesh (AP) and Gujarat.

Licenses of 18 Indian pharma companies were cancelled based on the risk-based inspections planned in December last year. The Central Drugs Standard Control Organization (CDSCO) 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 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 in the past six months. The CDSCO had identified around 203 pharma companies and more than 25 pharma companies were 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 risk-based inspections are based on the current good manufacturing practices (cGMP) and good laboratory practices (GLP) under the Drugs & Cosmetics (D&C), Rules, 1945.

These inspections which are jointly conducted by the state drug licensing authorities and the Drugs Controller General of India (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.

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