The DCGI office has filed counter affidavits in the Madras High Court praying to vacate the stay orders on the DCGI's order centralizing the issuance of Certificate of Pharmaceutical Product (CoPP). The DCGI office will file another counter affidavit in the Karnataka High Court in a day or two for the early vacation of the stay order there on the same issue.

Sources said that in the counter affidavits, the DCGI has pleaded that issuing of CoPP is not the job of the state drug authorities as is being pleaded by a section of the pharma industry. In all their submissions to the court for the stay of the DCGI order, the industry is learnt to have pleaded that issuing of CoPP is the job of state drug authorities.

How can it be the job of the state drug authorities when the CoPP issue is not even part of any statute, the DCGI office pleads. Since there is no subject as export in the Drugs and Cosmetics Act, state drug authorities are not empowered to issue the CoPP. It is a WHO issue, and the WHO has asked the national regulatory authority (NRA, which means DCGI office) to issue the CoPP to ensure quality of medicines being exported from this country, the DCGI is learnt to have pleaded with the court in its affidavits.

Three stay orders are pending in the Madras High Court and one in Karnataka High Court. The court granted the first stay order on the DCGI's order on CoPP on October 13 this year against a petition filed by D I Dileep Kumar, the secretary of the Tamil Nadu Drug Inspectors Association. Again the court granted stay on this issue on October 16, this time the petition was moved by B Sethuraman, chairman of the Federation of South Indian Pharma Manufacturers Association which has members spread across the four states of the South India.

The third stay was granted by the Madras High Court on October 23, and the petition was filed by Confederation of Indian Pharmaceutical Industries (CIPI) which has members across the country.