The health secretary to the government of Pondicherry, G Ragesh Chandra has issued show-cause notices to 20 pharmaceutical manufacturing companies operating in the Union Territory for violation of provision of 122E of the Drugs & Cosmetics Rules.

The action is the latest in the one-month enquiry conducted by the health department on the secret alliance between the former licensing authority M Rajkumar and a section of manufacturers on getting manufacturing licences for combination drugs, said the health secretary.

Speaking to Pharmabiz, Ragesh Chandra said prior approval of the drugs controller general of India (DCGI) is required to manufacture fixed dose combination (FDCs) drugs. But some companies in Pondicherry went ahead with the production of  formulations without the permission of the national regulator after establishing a secret alliance with the former state licensing authority, M Rajkumar. He said, following allegations of corruption, Rajkumar was suspended seven months ago and started enquiries, followed by it action is taken on cases with evidence.

He said the government of Pondicherry will comply with the rules of the national regulator and no illegal activity will be allowed. The government is very much concerned about the health of the people. So far 20 manufacturing units have been issued show cause notices seeking explanations and asking why their respective registration and licences should not be cancelled. According to him, more companies are in the list to be given the notices, and the process is on.

“More than 500 fixed dose combinations (FDCs) are available in Pondicherry and are manufactured without the approval of DCGI. The safety and efficacy data of many of these drugs are not with the authorities and there is no document of any trials done. The drugs are manufactured in Pondicherry, but not sold here; rather they are sold in Punjab, Haryana and in Kerala. We have all the reports. Such drugs will not be allowed for manufacture in Pondicherry and action will be taken against those manufacturers,” the health secretary told Pharmabiz.

When asked whether Pondicherry will witness any shortage of medicines, he said there will not be any problem and the department is ready to handle any such situation. All the illegally made combination drugs will be banned.

To another question if the government will support the small scale pharma enterprises there, Ragesh Chandra responded, “We will support all the industry in the rightful way. We will not in any way support illegal activities affecting the health of the people either in Pondicherry or in any other place.” He assured that he would cancel all the licences of the manufacturing units which have adopted illegal methods.

A senior drugs control official said Pondicherry is the first state in the country where action was taken against the manufacturers for violation of 122 E of the Drugs and Cosmetics Rules. He added that the state authorities had taken action first against the regulatory official who was found guilty, and then proceeded to industry owners for their misdeeds.

Meanwhile, the members of the Pondicherry Drugs Manufacturers Association (PDMA) have severed their ties with the organisation and joined the national body, Indian Drugs Manufacturers Association (IDMA). The present status of PDMA is in dissolved state, said a former member of the unit.

When contacted M Rajaratinam, the president of Tamil Nadu and Pondicherry unit of IDMA, said that his association will cooperate with the government of Pondicherry for all enquiries and all the manufacturing units will be directed to comply with the acts and rules. He said no member of his association will be allowed to do illegal things and the association is very much concerned about the health of the people.

Rajaratinam further said the manufactures of Pondicherry were of the impression that the government of Pondicherry was trying to relax the rules for the promotion of the industry and the former SLA might have been using his ‘discretionary powers’. But the joint secretary of IDMA, Prem Kumar said Pondicherry will soon witness severe shortage of essential drugs.