The Maharashtra Food and Drugs Administration (FDA)-Pune division, recently issued a show-cause notice to Cipla demanding explanation from the drug major as to why they were not complying to the storage conditions as required under the Drugs and Cosmetics (D&C) Act to store drugs in their Pune Western warehousing compound.
B R Masal, joint commissioner (drugs), FDA, Pune division said that following a visit to Cipla's warehouse, it was found that the company was flouting the rules by storing the goods improperly. Eighty one samples were taken from the site and sent to the government laboratory in Mumbai for analysis. The surprise visit to the Cipla’s warehouse was carried out by FDA Pune after receiving a complaint by Narendra Jain, national convener of Pharma Gladiator (India) in public interest on May 16.
During the surprise visit last month, the FDA officials found that the company was storing their products worth around Rs.4 crore under storage condition that is deemed to be inappropriate under the law as it could affect the quality and efficacy of the drugs. In the initial investigation it was discovered that the goods having tags that required to be stored below 25 degree centigrade and below 30 degree centigrade or that required to be stored in cool place were found to be stored at 36 degree centigrade.
A show-cause notice was later issued to Cipla regarding the same on June 8 by the FDA authorities demanding the company to give their stance on the situation. It is understood that the company has already replied to the notice claiming that they have not flouted any rules under the law and would do an internal inquiry to find the reasons for the above incidence. In the reply they have assured to the regulators that henceforth they will take special care to ensure that such events do not occur in future.
It is understood that the FDA is at present waiting for the test results which is expected to be received by end of this month for further action. |
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