The Pondicherry government may soon start revoking the drug manufacturing licences of several drug companies for violation of provision of 122E of the Drugs & Cosmetics Rules, it is learnt. The action is taken following the companies’ alleged nexus with a corrupt regulatory officer who is now under suspension, a senior officer in the drugs control department informed Pharmabiz.

According to him, more than ten manufacturing companies have been awarded production licences for manufacturing combination drugs by the suspended officer when he was in charge of state licensing authority.

As per provision 122E of the Drugs and Cosmetics Rules, the companies have to get approval from the DCGI for the manufacture of combination drugs, followed by it, permission of the state government is required. But in Pondicherry the manufacturing companies have violated the rules and cheated the government through a secret understanding with the suspended SLA, said the officer.

“Without getting approval from government of India they applied for permission from the state government and the officer in charge had granted them the product permission. On finding this, the SLA official was suspended from service six months ago. Following it, an enquiry has been conducted by the central investigating agency and it is learnt that the agency will file the charge sheet in the court shortly,” he said.

While speaking, the officer said the drugs are not at all approved by government of India. Such drugs cannot be marketed anywhere. The department is reviewing the licences issued by the former licensing authority.  Notices are being issued to the companies to submit all their documents immediately to the department for verification.

He said the manufacturers are not cooperating with the office for verification work. If they cooperate with the department, government will not take action against the companies other than cancelling the product licences given by the suspended SLA official. Else, the department will cancel the factory licences also.

“The state health secretary has issued circular to the present licensing authority to review the old documents of all the manufacturing companies and cancel them after verification. We will recall all the documents for verification and are ready to award new licences as per the acts and rules provided the companies respond to our queries and cooperate with us. We are not against any company or business, but everything should be based on law,” he said.

To a query he said several companies’ names are likely to be reflected on the charge sheet and that may be reason they are not filing papers with the department. Meanwhile, fearing the department action several companies have downed the shutters of their factories and fled the union territory to some other places, it is learnt.

Some company owners were reluctant to speak to Pharmabiz, but the president of Pondicherry Pharmaceutical Manufacturers Association (PDMA) A Karunakaran said all the members of his association are tendering their resignations. Neither the president nor any other office-bearer has commented anything on the present situation.

While speaking to M Rajaratinam, the president of IDMA Tamil Nadu and Pondicherry state unit, he said the problem will be solved soon and the factories which have closed down will be reopened shortly. He said 48 companies from Pondicherry have recently joined IDMA severing their ties with PDMA.

J Jayaseelan, secretary of IPA Tamil Nadu and Pondicherry responded that the situation in the union territory was very critical.