The union health ministry today has announced that the CDSCO will be acting as the competent authority for issuing clearance certificate for each of its consignments ensuring compliance of the product with the good manufacturing practices (GMP) requirements of EU. This comes as a huge relief to the industry which has been confused and affected by the new EU Directive which requires all the active pharmaceutical ingredients (API) exporters have to submit quality certificates to the European authorities to prove the quality of their products.
The Directive on falsified medicines, which is going to be implemented from July 2, 2013, is aimed at preventing falsified medicinal products from entering EU from other countries. As per the directive , the APIs meant for medicinal products for human use would require written confirmation for each API unit by the enforcement authorities of the exporting countries confirming complaints with GMP standards or rules 'equivalent to the rules applied in the EU', such as WHO GMP, 'International Conference for Harmonization' Q7 (ICH Q7), etc.
In this regard, the Pharmaceuticals Export Promotion Council of India (Pharmexcil) will be sending a representation to the ministry of commerce and the drug controller general of India (DCGI) urging them to develop detailed guidelines on the process of certification for the benefit of the industry. According to Dr P V Appaji, director general, Pharmexcil, they have already initiated the process so and will soon be meeting up with stakeholders from across the country to get their suggestions on this matter.
He stressed, “Now that the government has announced that CDSCO will be acting as the competent authority for issuing the certification we would like the government to take a pro active stance on this issue at the earliest. We are sure that the regulatory body will be supportive in taking all the right steps keeping in mind the best interest of the industry at large. As a step towards achieving this goal we are planning to send a high level representation to the centre proposing certain agendas to ensure transparency and detailing in this matter. We hope that the government will soon start working on these guidelines so that we can start analysing the current status on a wider scale.”
He further informed that they are planning to propose to the DCGI to deliberate over the possibility of accepting the certification of the companies who already have obtained or renewed the COPP certificate for API’s under the WHO GMP certification, a condition which is already been agreed upon by the European Union (EU). They also plan to propose fast clearance of the application preferably within 30 days from the zonal offices of the CDSCO for faster and efficient delivery of services.