In a big blow to the Central Drug Control Administration, the Madras High Court on last Thursday issued for the second time an injunction staying the order of the Drugs Controller General of India (DCGI) by centralizing the issuance of CoPP (Certificate of Pharmaceutical Products).
The court has issued the interim order acting on a petition filed by B Sethuraman, chairman of the Federation of South Indian Pharmaceutical Manufacturers Association. The injunction will be in force until further orders.
The injunction of the court restricts all the CDSCO offices in south India in implementing the order of the Central Drug Regulator. The DCGI issued the order in last month directing all the zonal and sub-zonal offices of CDSCO to issue CoPP through their offices from October 1.
The Madras High Court on last Tuesday had issued a stay order on the same issue hearing a petition filed by the Tamil Nadu Drugs Control Officers Association. The DCGI's order was to restrict the issuance of product manufacturing licences by state drug regulating agencies, who were hitherto issuing the certificates.
When contacted the assistant drugs controller, Santhi Gunasekaran, who is in charge of CDSCO, Chennai zonal office, said, "We have not been given any information about the court order. We got to know about the court verdict only from Pharmabiz. If it is true, we will fight it out, as it is our duty to implement the order of the DCGI. The DCGI's order is our order, we have to implement and safeguard it.
B Sethuraman, who is also the president of Pharmaceutical Manufacturers' Association of Tamil Nadu, said, the order of the High Court comes as a boon for the small scale pharma manufacturers of the country.
"We were in dilemma on hearing the news about the DCGI's directive. How can he issue such a directive as he is not the licensing authority, he is only the approving authority. How can the entire manufacturers of Kerala, Tamil Nadu and Pondicherry go to the zonal office in Chennai in getting the certificates? Now, only one drug inspector is working there, how can he look after all these companies? So far we were getting the licenses from the state authorities. Here every district has got one ADC who is able to sign the certificate. Even the state drug controllers are more experienced than the drug controllers of the CDSCOs," Sethuraman who secured the court order on behalf of the manufacturers, said.
T S Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industry (CIPI) commented that it was impracticable for the central agency to control all the state pharma industry when state regulatory agencies were there. "The Central agency is acting on WHO guidelines, but WHO did not say any specific agency to sign the certificate. It is impossible for the Central drug administration to handle all the problems. I am happy over the court verdict," he told Pharmabiz.