Close on the heels of a land mark agreement proposed between India and Germany for fast track approval of drug products to facilitate easy exports, the World Health Organisation (WHO) has mooted a uniform regulatory approach for the member countries, which will expand the scope of Indian drug exports to many more countries through rapid clearing process.
Towards this, the WHO had last month held a meeting of top drug regulatory officials from selected countries. It had also convened a workshop for regulatory officials in Geneva to formulate a systematic quality audit and regulatory framework for products and facilities in all the major pharma destinations in the world.
Once the system is implemented, the member countries can avoid duplication of quality audits of products and facilities if they had already undergone a commonly-accepted regulatory clearance in any of these countries, thereby facilitating a fast clearance of pharmaceutical imports and exports.
The proposal will help India, one of the most cost-effective location for pharmaceutical production, to increase its growing generic exports multifold in a hassle-free regulatory environment.
With over 100 manufacturing units which have international drug regulatory approvals for both bulk drugs and formulations, Indian pharmaceutical industry is all set to achieve significant gains from both the German pact as well as the WHO proposed commonly accepted regulatory regime.
Since exports being the prime focus of all the the top Indian pharma companies now, the country's share in the world generic market has grown by more than 25 per cent this year compared with last year.
"India has just started exploring over $57 billion worth world generics market. The country's share, which is currently around 14 per cent in this huge market, is expected to touch 50 per cent by 2010," says a senior industry analyst.
As per the German fast track approval deal that is likely to be signed soon, Germany would facilitate easy exports of pharmaceutical products manufactured from US FDA or EU approved manufacturing facilities in India.
Germany is the third largest pharmaceutical market after the US and Japan. Four Indian companies -- Ranbaxy, Dr Reddy's, Wockhardt and Torrent -- have already set up or acquired own drug manufacturing facilities there.
While the local manufacturing base has helped these companies access German markets in a faster manner, a fast track agreement could help rest of the companies that have manufacturing facilities and products of international standards.
The fast track approval agreement with Germany is expected to result in similar understanding with other EU companies.
"We are going to take up mutual recognition of Good Manufacturing Practices (GMP) certification for drug manufacturing units as an agenda item in the second Indo-EU working group scheduled to be held here in April 2007.
The agreement with Germany would help us go a long way in materialising a mutual recognition agreement with other EU member countries", G S Sandhu, joint secretary, department of chemicals and fertilizers told Business Standard.
The proposal was made before the German authorities a month ago. "We are expecting a team of experts from Germany to visit India soon. They will be asked to inspect all our world class drug manufacturing facilities.
Once they are convinced with our quality, we will go ahead with a fast track approval agreement, he added.
EU is one of the major export markets for Indian pharmaceutical industry and accounts for over 25 per cent of its total drug exports. India has a similar agreement for fast track approval with Tunisia at present.
