The DCGI office will soon file an application in the Madras High Court for early vacation of the stay orders on the DCGI's order of centralization of the issuance of Certificate of Pharmaceutical Product (CoPP). During the last fortnight, the Madras High Court had granted three stay orders on the issue to three different parties.
According to sources, the DCGI office is leaving nothing to chance this time as it did not want the matter go on the same lines of FDC issue. Even after several years, the FDC issue is still lying with the courts. In order to avoid such delays on this CoPP issue, the DCGI office is making preparations to plug all the legal loopholes for the early vacation of the stay orders. Even though the stay orders have been granted for a period of 8 weeks, the DCGI office is taking initiative to vacate the stay much before that.
Though the final document in this regard is yet to be prepared, sources said that it will be a foolproof document to apprise the court of the importance of the issue. As the CoPP is a stamp of quality of their product to show to the overseas markets, the DCGI office will apprise the court that the issue has attracted worldwide attention. The DCGI office will also plead that the entire exercise is being done to boost the image of the country's drug regulatory system, especially in the wake of steady increase in export of pharma products from the country. The DCGI office will file the application for the early vacation in the Madras High Court somewhere next week.
Three stay orders are pending in the Madras 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.