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Drugs Controller General of India (DCGI) Dr. Prior to the creation of a circular, pharmaceutical yogas signed by Rajiv Singh Raghuvanshi, “underlines the significant importance of testing raw materials.”
This follows the tests that have detected laps by some manufacturers in the testing of raw materials and finished products, which contributes to concerns on the quality and safety of the drug.
According to the CDSCO, inspection in the investigation of manufacturing facilities and later “not of standard quality” has shown that many manufacturers were not testing each batch of passive and active ingredients for compliance of the standards prescribed before use in production.
The instructions repeat the legal requirement under Drugs and Cosmetics Rules, Rule 74 (C) and Rule 78 (C) (ii) of 1945, which says that each licensee must test each batch or lots of raw materials or a lot of raw materials and final products-or in their laboratory or through the facility approved by the government. According to Schedule U of Rules, manufacturers are also required to maintain a wide record of such tests.
Dr. Raghuvanshi has urged all states and UT drug controllers to take immediate measures to ensure compliance, including intensive inspection, testing procedures monitoring, and making drug manufacturers sensitive through official circular. He has also emphasized that companies should have a strong seller qualification system and only a source of raw materials from reliable, approved vendors.
After several incidents of contamination in cough syrup in communication, regulator reflects vigilance, both in India and abroad are associated with adverse health results.
The latest step of CDSCO wants to plug the systemic intervals in the drug quality control and to tightly ensure public health protection to inspect the test protocol in the supply chain.
According to communication, state drug officials have been directed to take strict action and report back on such tasks taken in response.
(edited by : Ajay Vaishnav,