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Indian Drug Regulatory Processes Aligned With Global Standards, Says DCGI

Drug Controller General of India (DCGI) VG Somani said he doesn’t have doubt on quality of Indian drugs, adding that the system has no room for quality offenders.

India is far ahead in making accessible, affordable medicines and is very serious about the quality of drugs, according to him. Companies that do not follow the quality protocol have seen strict actions like sealing of their plants and jailing the wrongdoers.

“From Pfizer to Eli Lily to even small Indian firms we have taken action if quality is not met. We just do not name them on the website because pharma companies are doing good work also, so we do not want to discourage them,” Somani said at the India Pharma Forum 2020 in Mumbai.

Speaking on the case of ‘poisonous cough syrup’ that killed 12 children in Jammu & Kashmir, DCGI said a thorough investigation is underway. All of the manufacturing plants, raw materials and companies of the Himachal Pradesh-based Digital Vision company have been sealed.

“Investigation on the reasons whether it was the fault of irrational medication or medical negligence or the product was itself faulty.”

Indian drug regulator has been criticised in the past for laxity in taking action against low quality drugs and manufacturers.

“Not all of international regulators (US & EU) views on drug regulatory issues are not always right, India has been supplying affordable drugs to 195 countries for so many years. The amount of problems occurring in Indian companies is similar to other geographies.”

DCGI is selecting best practices from other regulators to make a common minimum agenda on inspections. “Collaboration, rationalisation with international standards is better than harmonisation when it comes to inspection guidelines,” he said.

While the Indian drug regulator has assessed joining PIC/S, the international cooperation between global regulators to share inspection resources and results, the industry is not too supportive, he said.

Even the World Health Organization has cautioned against joining PIC/S highlighting concerns that it might lead to over-regulation and in turn affect affordability and accessibility of the drugs.

With the government allocating Rs 1,850 crore for revamping the CDSCO, the drug regulator is focusing on strengthening DCGI staff strength, training, setting up more labs, mobile labs among others initiatives. The focus is on simplifying regulations for better compliance and digitalisation of its systems and processes to make it more transparent.

The regulator said once all details of inspection and regulatory actions starts coming on the website, transparency will go up. “Almost 90 percent of the work to bring systems and services online will be completed by end 2020,” Somani added.-CNBC18

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