Mumbai : The Gujarat Food and Drug Control Administration (FDCA) has canceled licenses of two companies for gross non-compliance to norms and stopped production of one company as part of the risk based inspections.
Risk based inspections will be ongoing in the state in line with recent pan-India Centre-State joint inspections. Centre has mandated a Zero Tolerance Policy on compromising drug quality and patient safety.
“A total of 5 companies have come under the scanner in the recent third phase of risk based inspections. Two more companies out of the five inspected have also been served show cause notices (SCNs) for non-compliance,” informed Gujarat FDCA Commissioner Dr H G Koshia.
The Centre is also in the process of revising its good manufacturing practice (GMP) guidelines for medium, small, and micro enterprises (MSMEs) engaged in making drugs.
Around 162 units and 14 public testing labs have been inspected as part of the risk based inspections and inspections have revealed poor documentation, lack of process and analytical validation, infrastructural deficiencies, unqualified employees, and faulty design of manufacturing and testing areas.
The Gujarat FDCA had earlier cancelled 15 product licenses of 6 pharma companies based on risk-based inspections. The inspections revealed that the products of some of the companies like widely prescribed gastrointestinal medicines and vitamins were not-of-standard quality (NSQ). Products also included medicines like azithromycin for cold and amoxicillin for bacterial infections.
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 earlier this year. The CDSCO had identified around 203 pharma companies and more than 25 pharma companies were issued show cause notices.
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.
