Well ahead of the deadline to implement the European Union (EU)’s 'Directive on Falsified Medicines', India has put the mechanism in effect by issuing the first written confirmation (WC) certificate in line with the requirements set by the EU.
Drugs Controller General of India (DCGI), who was made the competent authority by the Union health ministry to issue the WC, granted the certificate to global leader Teva API India, thus pitching India on the track well in time before the EU directive comes into effect from July 2, this year.
The certificate was issued to the API manufacturing plant of Teva Pharmaceuticals, based at Ghinrongi in Bhind district of Madhya Pradesh, for nine active ingredients for manufacturing and packing. Clopidogrel bisulphate USP, olmesartan medoxomil, clarithromycin Ph. EP, losartan potassium EP, atorvastatin calcium USP, Irbesartan EP, quetiapine fumarate, sitagliptin phosphate and sitagliptin malate are the products that will now have smooth landing in EU.
“The issuing regulatory authority hereby confirms that the standards of good manufacturing practice applicable to this manufacturing plant are at least equivalent to those laid down in the EU (GMP of WHO/ICH Q7). The manufacturing plant is subject to regular, strict and transparent controls and to the effective enforcement of good manufacturing practice, including repeated and unannounced inspections, so as to ensure protection of public health at least equivalent to that in the EU,” according to the Certificate which will be valid till May 2016.
As per the certificate, issued on May 15, inspection of the plant was carried out on 13 and 14 of June 2011. The letter to the company by the DCGI also made it clear that the WC will be withdrawn in the events of non-compliance of standards.
The certificate was made necessary for import of active substances into EU for medicinal products for human use in accordance with the Article 46(2)(b) of EU Directives No. 2001/83/EC, which is aimed to prevent falsified medicinal products from entering EU from other countries. Each API unit requires WC by the enforcement authorities of the exporting countries confirming compliance with GMP standards/ rules 'equivalent to the rules applied in the EU', such as WHO GMP, 'International Conference for Harmonization' Q7 (ICH Q7), etc. effective from July 2, 2013.
The DCGI had recently issued detailed guidelines for issuing WC. It had specified that the first WC would be issued based on valid Certificate of Pharmaceutical Product (CoPP) issued as per WHO guidelines or US FDA or EDQM/ TGA certificates (not more than 24 months old). If the company does not have any of these, then inspection will be conducted.
Earlier in November last year, the union health ministry had made the CDSCO (DCGI office) as the competent authority for issuing WC certificate for each of its consignments ensuring compliance of the product with the good manufacturing practices (GMP) requirements of EU.