DCGI To Undertake Massive Risk Based Inspections


Mumbai : The Drugs Controller General of India (DCGI) will soon undertake massive risk based inspections pan-India following the World Health Organization (WHO) holding Indian company Maiden Pharmaceuticals accountable for exporting contaminated medicines.

This comes close on the heels of the Indian drug regulator asking for more sophisticated tests to prove cause-effect linked to deaths of Gambian children due to contaminated medicines and with the WHO holding the Haryana-based Maiden Pharmaceuticals accountable for exporting contaminated medicines. The global health agency and a Gambian parliamentary panel recently reaffirmed that the contaminated cough syrups were imported from India days after the DCGI said samples tested in India had been found of standard quality.

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. 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,” informed an official associated with the development.

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.

According to a pharmaceutical company dealing in drug development and manufacturing, “Even though the Indian plant might be designed to cater to the Indian market, it should ideally comply with the norms as per the US FDA or authorities in the regulated markets. We don’t see the Indian pharmaceutical companies developing innovative molecules. Most foreign companies would not like to take the risk of manufacturing patented molecules in India largely because of the trust deficit about manufacturing quality medicinal products in India.”

“Observations have been made related to data integrity issues, warning letters, import bans and quality oversight not being maintained for Indian pharmaceutical companies. So unless and until Indian companies don’t adhere to quality norms, this will keep on happening. 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.


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