In huge relief to the Indian pharma exporters, the ministry of health is soon expected to approve the final guidelines enlisting the requirement set by the DCGI to issue written confirmation for each API unit. These guidelines give a detailed set of requirements that the Indian exporters have to undergo to ensure undisrupted  export of APIs to European Union (EU), once the EU Directive on Falsified Medicines comes into force on July 2, 2013.

As per a highly placed source from the ministry, the DCGI, after elaborate deliberations with the commerce ministry, has already submitted the finalised guidelines to the ministry of health for their approval in mid March. Considering the impact and the importance of the same on the exports, the commerce ministry and Pharmaceuticals Export Promotion Council of India (Pharmexcil) are said to be closely working with the Ministry of health on the this matter on a daily basis for immediate action plan.

Understanding the fast approaching implementation date of the EU directive, the DCGI is reported to have considered two options in the final document for approval from the ministry. The DCGI has reportedly indicated the possibility of  issuing clearance certificates for the first time, based on WHO GMP certification the units already have along with the certificates from the FDAs regulating that market and later go for the inspection of the unit.

While the second option indicated that the DCGI's office may first issue the written certificate, this again only for the first time, while undertaking the inspection of the site for ensuring compliance of the product with the good manufacturing practices (GMP) requirements of EU soon after the issuance of the certificate so that the companies do not suffer from the delay.

It is understood that the finalised guidelines have been modified and prepared after thorough discussions with the stakeholders and the policy makers to ensure that exports do not suffer in the process of meeting the deadlines of the EU directive.

According to Dr P V Appaji, director general, Pharmexcil, they are fairly positive that the ministry will soon take up its final call on this matter at the earliest as time is running short. He informed that to ensure that no exporters are led to suffer due to the delay in the issues of certification once the EU directive is implemented all steps are being taken by the commerce ministry with due diligence to follow up on this matter with the DCGI and the health ministry.

As per the directive on falsified medicines, which is going to be implemented from July 2, 2013, all the APIs meant for medicinal products for human use would require written confirmation for each API unit by the DCGI's office confirming compliance with GMP standards or rules 'equivalent to the rules applied in the EU.

The main reason behind adopting this directive by the EU is reportedly said be aimed at preventing falsified medicinal products from entering EU from other countries.