New guidelines for pharma exporters to EU announced

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SME Times News Bureau | 23 May, 2013
The government has announced a set of guidelines for Indian exporters of pharma products to the European Union to help the sector meet new standards for import of bulk drugs into the 27-nation economic block.

In a official press statement, the Ministry of Commerce and Industry said, "The Department of Health & Family Welfare officially declared the Central Drugs Standard Control Organization (CDSCO) on 12.11.2012. It was also decided that a protocol for the procedure to be complied by the India Active Pharmaceutical Ingredients (API) Exporters would be laid down by the CDSCO which has been done."

European Union issued a new Directive to lay down a community code relating to medicinal products for human use and to ensure that the defective products do not reach consumers. The Directive lays down a system of control over the entire supply chain for pharmaceuticals. It controls manufacture and import to marketing, wholesale and retail distribution.

The new EU directive will be operational from July 2, 2013.

Under current regulation, exporter of APIs to EU countries should either have a Certificate of Suitability (COS) issued by EU Authority of a Drug Master File (DMF) filed with respective Regulatory Authorities of the respective Member State.

Also a Qualified Person (QP) of the company in EU intending to use the API has to certify that the API is manufactured under Good Manufacturing Practice (GMP) prescribed in International Conference for Harmonisation (ICH) guideline Q7A.

"The Department of Commerce has been seized of this issue right from the beginning since EU is an important market for the pharma industry. Various EU industry members have been expressing their concern about the ability of India to comply with the new procedure by the deadline of 2nd July 2013. However, Government of India is optimistic that its pharma industry would be able to meet regulatory requirements within the given time frame," said the release.

According to CDSCO guidelines, application for issue of "written confirmation" for APIs for medicinal products for human use is to be made by the exporter in prescribed format. After satisfying the completeness of documents submitted, inspection shall be conducted and after satisfactory outcome thereof, formal written confirmation shall be issued.

In addition, the release stated that non-compliance noticed after inspection shall be communicated to the EU as per their requirement. A time frame of 45 days has been prescribed for disposal of satisfactory applications and the written confirmation shall be valid for the three years.

Detailed forms have been laid down for purposes prescribed under various Articles of the EU Directives by the CDSCO - running into nearly 70 pages.

The commerce ministry said that in due course of time, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the system.

"Compliance by pharma industry with the EU directive is expected to have a very positive impact on the companies as many of them aspiring to export to the developed countries shall in the process upgrade their plants to WHO GMP standards," said the release.

The detailed guidelines laid down by CDSCO and also approvals granted for various exporters are available at http://www.cdsco.nic.in/ .