The CDSCO zonal office in Chennai has informed the Madras High Court that there is no provision in the Drugs & Cosmetics Act or Rules giving statutory right to the state drug control authorities for issuing Certificate of Pharmaceutical Products (CoPP) or regulating export of drugs. The Act has just a provision for the labelling of drugs under Part 1X of the D&C Rules, 1945.

In the writ petition filed in the Court by Tamil Nadu Drugs Control Officers Association (TN DCOA) on October 12 seeking a stay order for the circular issued by the DCGI, M Dilip Kumar, the secretary had stated that the CoPP was being issued by the drug control officers of the state under the provisions of the D&C Act and Rules for decades.

In the Affidavit filed in the court on November 11 by the ADC of the Chennai zone of CDSCO against the writ petition, it has been asserted that the right to sign and release of the CoPP is a voluntary function of the National Regulatory Authority to implement WHO GMP certification scheme in India on the quality of pharmaceutical products moving in the international commerce.

The ADC, Shanthy Gunasekaran, on behalf of the DCGI has further informed the court that the WHO empowers only a national and centralized regulatory authority of a country as the competent authority to issue the CoPP. In India, DCGI is the competent authority and he has delegated temporarily this power to various State Drugs Control Authorities. But, he has never notified the state drug controllers under WHO CoPP scheme, she stated in her affidavit while denying certain points mentioned in the writ petition.

In the counter affidavit it was stated that the petitioner representing TN DCOA has misled the court by making it believe that the issuance of the certificate by the state authorities is a statutory right vested to them under the provisions of the D&C Act. The ADC also denied that the state drug authorities were designated as certifying authorities by WHO to issue the certificate.

The CDSCO officer has categorically stated that in the 40th meeting of the Drugs Consultative Committee held on 29.06.2009, it was decided that CoPP certificates or model certificates of GMP would henceforth be issued by the DCGI for the purpose of uniformity and compliance to WHO guidelines. She has further stated that on March 17, 1998, the DCC had agreed that till such time the issuance of certificate at national level commenced by the centralized authority, the state drug control authorities would process the existing applications.

Further the assistant drugs controller informed the court that WHO has been time and again reiterating its stand that the WHO GMP certificate should be given only by the national regulatory authorities. The WHO in a letter sent to DCGI on 29.04.2009, has highlighted the fact that the conditions of WHO GMP Certificates with respect to issue of CoPP are not being adhered. WHO routinely undertakes assessment of the National Regulatory Authority of its member countries for certifying its capacities on various counts or indicators, Shanthy Gunasekaran stated in the affidavit.

Regarding the allegation of delay in issuing the certificates, the CDSCO office has informed the court that it was a false allegation against the office and there would not be any impediment in exporting products from Tamil Nadu. In view of the growing stature of India's image as the major pharmaceutical power in the manufacture, import and export of pharma products, the DCGI has been augmenting its office with additional strength of drug inspectors and assistant drug inspectors to cater to the needs of pharma industry and also to effectively regulate it. Further four new zonal and two sub zonal offices have been envisaged to be operational soon with state of the art machineries.

In the counter affidavit it was mentioned that there were various irregularities often observed in the CoPPs issued by the state drugs controllers which included different formats used as against the approved one, additional product certificates issued without joint inspections, not associating with the officials of the CDSCO for granting the certificates, and not forwarding the copies of CoPP issued by the state regulators to the DCGI office.