The DCGI office will file applications in the Madras High Court and Bangalore High Court for the early vacation of the stay orders on the DCGI's order of centralization of the issuance of Certificate of Pharmaceutical Product (CoPP). The Madras High Court had granted three stay orders to three different parties and the Bangalore High Court had granted one stay order on the issue.
According to sources, DCGI Dr Surinder Singh has accorded top priority to the issue and has asked his officials to expedite the works related to filing the cases in these courts. Legal advisors in the DCGI office are already in Chennai and Bangalore in this regard and the cases to vacate the stay orders will be filed in a day or two, sources said.
According to information, the DCGI office has prepared 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 foreign countries, the DCGI office will apprise the court that the issue has attracted the worldwide attention. The DCGI office will also plea 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.
Sources said that the DCGI office is leaving nothing to chance this time as it did not want the issue go on the same lines of FDC issue. Even after 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 eight weeks, the DCGI office is taking initiative to vacate the stay much before that.
Three stay orders are pending in the Madras High Court and one in Bangalore 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.