Exports of active pharmaceutical ingredients (APIs) from India to Europe is unlikely to be hit by the impending new European Union (EU) regulations on API imports, with most of the leading bulk drug players in the country securing written confirmation (WC) certificates well in time ahead of the deadline.
As per the information, so far 160 manufacturing facilities in India have been cleared by the Drugs Controller General of India (DCGI), who had been made the competent authority by the Union Health Ministry to issue WC in accordance with the EU 'Directive on Falsified Medicines', being implemented from July 2 this year.
The positive response by the domestic pharma industry has also given a better footing to India as apprehensions are reportedly building up in Europe over the negative impact of the rules and EU is learnt to be working on contingency plans to meet the possible shortage of APIs.
Sensing the urgency, almost 140 facilities got WC for the products during the month of June while 23 facilities were approved in May. The first company to get the WC was global leader Teva API India for its API manufacturing plant based at Ghinrongi in Bhind district of Madhya Pradesh.
Apart from Teva, all leading players like Ind- Swift Laboratories, Ranbaxy, Cipla, Dr Reddy’s, Cadila, Aurobindo, Biocon, Lupin, Glenmark, IPCA Laboratories, Jubilant Life Sciences, Fresenius Kabi Oncology, Cadila Pharmaceuticals, Wockhardt, Piramal Healthcare, Shasun Pharma, AstraZeneca, Sanofi, Mylan Lab, and Sun Pharma have secured WC certificates for their various manufacturing facilities.
IOL Chemicals and Pharmaceuticals Ltd, Norex Flavours Pvt. Ltd, Alchem International Ltd, Western Drugs Ltd, Parabolic Drugs, Coral Drugs, DSM Sinochem Pharmaceuticals India, USV Ltd, Glochem Industries, Natco Pharma Ltd, Mylan Laboratories, Aurobindo Pharma, Nakoda chemicals, PharmaZell (Vizag) Pvt. Ltd, Synthochem Labs, MSN Laboratories, Auctus Pharma Limited, Virchow Laboratories, Nosch Labs, Granules India, Glochem Industries Ltd, Divi’s Laboratories Ltd, Sri Krishna Pharmaceuticals Limited, Neuland Laboratories, Biocon, Hetro Drugs, Suven Life Sciences Limited, Lupin, Morepen Laboratories, RPG Lifescience, Glenmark Generics, Unichem Lab, Macleods Pharmaceuticals, Alembic Pharmaceuticals, Auro Laboratories, Anuh Pharma, Megafine Pharma, Orchid Chemicals & Pharmaceuticals, Arti Industries, Global Calcium, Orchid Chemicals and Pharmaceuticals, Dishman, Nectar Lifesciences and Bal Pharma are also among those who successfully applied for the WC certificates.
“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 a protection of public health at least equivalent to that in the EU,” according to the Certificates which will be valid till May 2016.
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.