Mumbai : The Gujarat Food and Drug Control Administration (FDCA) has cancelled 15 product licenses of 6 pharma companies based on risk-based inspections. Most of these companies are based out of Ahmedabad.
In the 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.
“Companies can now get their product licenses back only once they produce the stability data. These stability data studies have to be mandatorily done at Vadodara based testing lab. This could entail the company to do research and reformulate the product again in the interest of patient safety,” informed Gujarat FDCA Commissioner Dr H G Koshia.
These risk based inspections are happening for the first time in India and NSQ medicines have been reported from Uttrakhand, Himachal Pradesh (HP), Madhya Pradesh(MP), Andhra Pradesh (AP) and Gujarat.
The Central Drugs Standard Control Organization (CDSCO) recently stated that licenses of 18 Indian pharma companies have been cancelled based on the risk-based inspections planned in December last year. The 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 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 HP (70), Uttarakhand (45) and MP (23), as per official sources.
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 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.
