No consent: Drug units flout norms of production

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Visits to 18 bulk drug manufacturing units by the Expert Committee constituted by the Appellate Authority, between May 4 to May 17, revealed that samples from 15 of the units contained 74 drugs that had not received consent from APPCB for their production. Prior notice had been served to the units after allegations surfaced that many of them were manufacturing drugs that had no consent, and are manufacturing them in excess too.

The 18 industrial units had been notified that the Committee would make a visit in the first week of May after it had been asked by the Appellate Authority in March to submit a report within eight weeks seeking information from the units on the products they were manufacturing, quantities and other facts. The Committee’s letters also established why they were visiting and the procedure they would adopt to conduct the investigation.

Maa Telangana Party chief Veera Reddy, who first took up the issue, pointed out that if such a huge number of unauthorised drugs were being manufactured blatantly despite the units being forewarned of a visit, one could well imagine the scale at which such practices must have been going on all these years. These units bore no accountability on issues, such as pollution, in the manufacture of these unauthorised drugs, Mr Reddy said.

Hetero Drugs Limited, Unit 4, which was visited on May 7, had consent for manufacturing 16 of the products, but it was found to be manufacturing 27 that did not have consent. The Unit has applied for a Consent For Establishment for a new product mix. Unit 1 of the same company, with permission for 30 products, was also producing 17 others without such permission.

Similarly, SMS Pharmaceuticals, having permission to make three products, is actually making nine that are not among those allowed by the APPCB. Cirex Pharmaceuticals was found to be producing an equal number of unauthorised products (13) as the authorised ones. Aurobindo Pharmas were found to be producing 20 products in excess of the permitted 40.

Name of the Company
No of Products as per DFE/DFO
Consented Unconsented