Even as the issue relating to the issuance of Certificate of Pharmaceutical Products (CoPP) is pending with the Madras High Court for a final disposal, a statement made by Indian Drug Manufacturers Association which was included in the Counter Affidavit filed by the Chennai office of the Central Drugs Standard Control Organisation (CDSCO) on behalf of DCGI, has become a matter of discussion and dispute among the manufacturers and drug control officials.
In the counter affidavit submitted by the assistant drugs controller, CDSCO Chennai, Shanthy Gunasekaran said the IDMA had appreciated the initiative took by DCGI with regard to the issuance of CoPP. The ADC’s statement has become a bone of contention between the Tamil Nadu Drugs Control Officers Association and IDMA and finally the Association had to struggle to justify their stand as they are not in favour of the decision taken by the DCGI.
When Pharmabiz contacted IDMA in Mumbai, its secretary general Daara B Patel has clarified that they are not in favour of centralizing the issuance of CoPP and said they were quoted out of context. In an e-mail sent to Pharmabiz’s Chennai Bureau, Patel has mentioned that regarding the circular issued on September 1, 2009 by the DCGI in respect of centralization of CoPP, the IDMA expressed its reservation stating that currently neither the DCGI nor his zonal offices are equipped to issue CoPP without delay due to many reasons. He said as a matter of fact, the Association had appreciated the Madras High Court’s decision in keeping the circular in abeyance, and requested DCGI to instruct his officers and State Licensing Authorities in the country to maintain status quo.
However, in a letter sent to the DCGI by IDMA’ president N R Munjal on October 28, requesting him to keep his circular in abeyance following the Madras and Bangalore courts’ stay orders, it was mentioned that the Association was very eager to work closely with the DCGI in his endeavour to implement the new procedure smoothly through his subordinate offices all over India. Simultaneously he urged him to inform the SLAs to continue proper and quick issuance of CoPPs all over the country and automatic extension of old certificates for ensuring smooth flow of exports.
When the counter affidavit came for hearing in the court on November 18, the petitioner, M Dilip Kumar, secretary of the Tamil Nadu Drugs Control Officers Association was not present in the court, hence the case was posted for November 25 for further hearing.
“We have decided to pursue the case vigorously. We will argue in the court. There are so many misleading facts in the counter petition filed by Shanthy Gunasekaran. It is our duty to bring them to the notice of the court,” Dilip told Pharmabiz.
Meanwhile, assistant drugs controller, CDSCO, Shanthy Gunasekaran, said all the points made in her affidavit are true and have the supporting documents. She said the World Health Organization empowers only the National Regulatory Authority (DCGI in India) of a country as the competent authority for issuance of CoPP. She maintained that in the periodical meetings of Drugs Consultative Committee (DCC), the statutory body under the Drugs & Cosmetics Act held on several occasions from 1995, WHO had reiterated that there should be only one authority to issue the certificates for export purposes. The SLAs can process the application and cooperate in the joint inspection.
In her affidavit, she stated that many irregularities were found in the certificates issued by the state drug controllers which included different types of formats against WHO approved formats, issuance of additional product certificates without joint inspections and not forwarding the copies of CoPP issued by them to the DCGI office.