The Madras High Court has once again adjourned the case related to CoPP for February 1 for further hearing. This is the eighth time the case has been adjourned by the Madras High Court for another date without holding any argument.
On January 28 though the case was listed for hearing, it was not taken up by the court due to huge backlog of cases. When the case came up for hearing on January 29, Justice K Suguna has posted the case (WP 20862 / 2009) for next Monday, said Advocate Sankaran, government pleader.
The issuance of Certificate of Pharmaceutical Products (CoPP) became a major issue between the industry and the Drug Controller General of India (DCGI) ever since the DCGI issued an order to the state drug controllers in September last year under which the CoPP was to be issued by the CDSCO offices from October 1 last year after auditing by the CDSCO officials. Till then, the CoPP was issued by the state licensing authorities (SLAs) after a joint inspection by the CDSCO and state drug control department. The DCGI took this action of centralisation of CoPP in the wake of concerns expressed by the WHO on the lack of a single authority in issuing the CoPP in the entire country.
Following the DCGI order, the Tamil Nadu Drug Control Officers Association and industry associations like CIPI had challenged the order in the Madras High Court and the Court had passed an interim stay order on the issue on October 13.
The case came up for hearing first on November 18 and was postponed to November 25. On that day, in the absence of the petitioner, the court had moved the case to December 2. But the government pleader on December 2 pleaded for some more time in the court which again caused to post it for December 9, when the court after hearing the argument posted the case for December 21. The case was again adjourned for January 8 this year and later to January 18. On January 18, once again the court adjourned the case for January 28.
The case, which came up for hearing on January 29, has been dragging on in the Madras High Court for a final decision for the last more than three months. This is the eighth time the High Court is postponing the case to a further date.
CoPP is a certificate issued by the drug authorities to a specific product. It is accepted as a proof of the quality of a product. Presently CoPP is issued for two years. It is accepted internationally as proof of quality of a product especially in countries where there is no regulatory system of their own. While the US, European Union countries, Canada, Australia and other developed countries have their own regulatory system and they import the drugs approved by their own agencies like the US FDA, countries in Latin America, Africa, CIS countries and other developing countries accept CoPP as proof of the quality of the product.