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Pharma manufacturers to be trained in good manufacturing practices after USFDA concerns by CDSCO

Currently there are no common regulations in India for the pharma manufacturing practices as a result of which the USFDA has constantly issued warning letters to the Indian Pharmaceutical companies. Hence CDSCO (Central Drugs Standard Control Organization) has started a process aimed at implementing good manufacturing practices in industries. The USFDA recently issued warning letters to leading Indian pharma firms such as Dr. Reddy's, Lupin and Sun Pharma for violations of good manufacturing practices. The U.S-based drug regulator said its inspections in India have increased due to rising exports from the country.

CDSCO has engaged 500 personnel for the training process as according to GN Singh, Drug Controller General of India,” it is high time that proper practices and regulation are put into place for the pharma industry for India being one of the biggest generic industries in the world and to ensure that quality medicines are produced by India”. Drug manufacturing practices in India are regulated by state level authorities which according to GN Singh, has led to non-adherence to Good Manufacturing Practices. He also said that the Indian Government is currently following the MHRA (Medicines and Healthcare Products Regulatory Agency) standard which is less strict than USFDA.

The training initiative has been taken after around 200 Indian officials from CDSCO were trained by the USFDA in Nov 2015 on inspection techniques to establish good manufacturing practices at pharmaceutical facilities and due to the fact that currently a majority of the people engaged in the pharma manufacturing industry do not even know the national or international ethics of manufacturing. They do not know how to produce quality medicines. That is one reason why sub-standard medicines get manufactured. Even the records are not maintained properly. As a part of training initiative, the CDSCO officials would first visit Baddi (Himachal Pradesh) in the last week of May and train the officials of the five pharma manufacturing units there. Through this engagement, even the CDSCO officials will know the issues faced by the manufacturers.



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