DCGI Must Take Confidence Building Measures To Protect Waning Credibility Of Indian Pharma: IDMA
The Indian Drug Manufacturers’ Association (IDMA) has stated that the Drugs Controller General of India (DCGI) should usher in confidence building measures as part of risk based inspections to protect waning Indian pharma’s credibility amid negative media reports due to children’s deaths in Gambia and Uzbekistan due to contaminated medicines exported from India.
The DCGI has already started pan- India risk based inspection action plan following the World Health Organization (WHO), Gambian and Uzbekistan regulatory authorities reports about contaminated medicines being exported from India based on the test results drawn from the respective medicines which were found not of standard quality.
“DCGI should first discuss the test results or final inspection reports before making it public and then penalize the company before arriving at a conclusion based on evidence and a consultative process. The pharma companies need to be informed and educated on how to be audit ready to face such pressing issues like import bans and warning letters. This according to the IDMA is very much required at the moment as India’s image as the Pharmacy of the World has taken a big set-back due to the ongoing rumour mongering and negative media reports about the Indian pharma industry due to the import bans,” said IDMA secretary-general Daara Patel.
Based on the lab reports, the WHO had held Haryana based Indian company Maiden Pharmaceuticals accountable for exporting contaminated cough syrups for children.
The Noida-based Marion Biotech has also come under the scanner now after the death of 18 children in Uzbekistan. The Union Health Ministry, Government of India (GoI) has alleged that the children have died after consuming its cough syrup, Doc 1-Max. The Union Health Ministry and regulatory bodies have initiated an investigation against the company. The Union Health Ministry has also stopped manufacturing activities of Marion Biotech at the Noida unit.
Based on the Gambian regulatory authorities and the WHO reports, the Indian drug regulator had asked for more sophisticated tests to prove cause-effect linked to deaths of Gambian children due to contaminated medicines. Laboratories in Ghana and Switzerland contracted by the WHO confirmed unacceptably high levels of diethylene glycol (DEG) and ethylene glycol (EG) in them. The two chemicals can cause acute kidney injury and lead to death.
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. These inspections are based on the current good manufacturing practices (GMP) and good laboratory practices (GLP) under the Drugs & Cosmetics, Rules, 1945. These inspections 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.
