Although High Courts of Madras and Bangalore already stayed the order of Drug Control General of India asking the CDSCO offices to issue the Certificate of Pharmaceutical Products (CoPP) from October 1, some zonal and sub-zonal offices of CDSCO are going ahead with the process of issuing the same without considering the judgements of these regional courts.
The sub-zonal office in Hyderabad has issued 10 Certificates of Pharmaceutical Products within twenty days of the issuance of the order. Whereas, Bangalore and Chennai offices have stopped the 'speedy movement' of the process after the court order. When contacted the officials of these offices said they have not been conveyed any court order staying the DCGI's circular, so far.
A Chandrasekhara Rao, CDSCO- sub-zonal officer, Hyderabad said, "We are getting applications and the office is issuing the certificates. We are following the instructions of DCGI. We have not been informed of any court order. After all, the manufacturers are happy in receiving certificates from our office. I have called a meeting of all the manufacturers with the help of Pharmaexcil and briefed them about the new order and they are happy. So I am not expecting a stay from Andhra high court against the order."
When asked how they conduct the inspections, he said that they have three drug inspectors and the process is going on as usual, but issuance of certificates is depending on factors.
The DCGI issued the order on September 9 this year, and it has come into effect on the very first day of this month. Immediately the drug control officers of Tamil Nadu and manufacturers of various states have approached the respective high courts objecting to the implementation of the order.
The petitioners were describing the circular of the DCGI as impugned and it is usurping the powers and functions vested with the State Drug Control Officers under the Provisions of the Drugs & Cosmetics Act. Further they have informed the court that the circular of the DCGI would harm the interest of drug manufacturers to participate in the global tenders and thereby it would be a huge revenue loss to the government.
On hearing the petition filed by Tamil Nadu Drug Control Officers Association, the Madras High Court had on October 13 issued an injunction staying the order of the DCGI. On October 15, the court has also pronounced the same judgment on a petition filed by Federation of South Indian Pharmaceutical Manufacturers Association, under its ambit, come the states such as Andhra Pradesh, Tami Nadu, Karnataka, Kerala and Pondicherry.
On October 16, the pharmaceutical manufacturers of Karnataka have obtained a similar verdict from the Bangalore High Court. According to sources, associations of drug control officers in other states and various pharma manufacturers associations are waiting for stay orders from various high courts in the country against the Circular sent by the DCGI.