Maharashtra FDA Executes "Surprise Inspection Spree" On Hundreds Of Pharma Units
December 3, 2014
By Mark Terry, BioSpace.com Breaking News Staff
The Maharashtra Food and Drug Administration (FDA) in Mumbai, India has instigated hundreds of surprise inspections of World Health Organization (WHO) certified pharmaceutical units, news that is being met “fear and anger” by the units and India’s pharmaceutical industry in general, said news reports Wednesday.
The pharmaceutical units received WHO certification after joint inspections performed by the Central Drugs Standard Control Organization (CDSCO) and state FDA. Of the 450 or more WHO certified pharmaceutical units, more than 50 have already been inspected. An unnamed industry source said in a Pharmabiz.com article, “It is surprising to note that these inspections seem to be targeted to units that already have WHO certification jointly inspected and issued by CDSCO and State FDA.”
Units already inspected include Wockhardt, Glenmark, Ajanta, Indoco Remedies, Cipla, Piramal, Sandoz, FDC, Manish Exports, Arti Drugs and others. Some of the units have been closed down as a result of the inspections and others have been issued “show causes,” apparently for minor problems.
“We fail to understand the reason for the drive as these units have been cleared by the same department,” an unidentified industry insider said in a statement. “So if there seems to be any doubt on the permission given to these units then it should have been taken up with the CDSCO on validity of WHO grant given to them. If the drive is taken on compliance issues logically then it should be done across the board and should start with the units that are not WHO certified.”
Indian pharmaceutical exports have dropped by 6 percent recently, which was of enough to concern to warrant a cabinet secretary-level meeting on November 28, 2014. India’s prime minister, Narendra Modi, has stated he planned to bring India from number 144 to number 50 by April 2015 for doing business in India. An industry delegation plans to meet with State Chief Minister Devendra Fadnavis to discuss the surprise inspections.
It’s possible these inspsections are related to recent reports of quality control issues with India-based Sun Pharmaceutical Industries Ltd. A U.S. Food and Drug Administration investigation found that some quality test results on drugs being shipped to the U.S. were falsified. The problems were not isolated to Sun, but involved 12 other companies in India as well.
The Indian government announced today that has formed a panel to fast-track investment proposals from U.S-based companies. This is designed to boost and smooth U.S. investment and business entry into the country. According to a statement released by the government, the panel “will identify bottlenecks faced by the U.S. investors in the implementation of their investment proposals and address them in consultation with all other agencies and state governments concerned.”