Hyderabad: A shortage of globally-recognized testing labs could impact India’s drugs and chemical exports to Europe, worth some $2.7 billion (about Rs11,500 crore) in 2007.
From 1 December, a new import regulatory regime aimed at reducing the environmental damage of chemicals in that continent kicks in with significant implications for India.
Exporters worldwide have to register with a European Union (EU) agency implementing a new legislation called Registration, Evaluation and Authorization of Chemicals, or REACH, by 30 November, failing which such trade will be suspended. REACH requires manufacturers of all chemical substances including pharmaceuticals, pesticides, dyes, cosmetic products and veterinary drugs to establish that their products are not hazardous to either human health or the environment.
To comply with REACH regulations, the chemical substances exported have to be registered with the European Chemicals Agency, or Echa. For the chemical safety reports required by the agency, manufacturers will need to run such exports through a host of tests at labs certified for so-called “good laboratory practices” (GLP), a quality standard evolved by the Organization for Economic Cooperation and Development (OECD) and approved by the EU.
Some 1,000 Indian firms exported nearly 700,000 tonnes of chemicals and allied products to the EU in fiscal 2007, according to the Indian Chemicals Council.
At present, India has just a dozen GLP-approved labs, half of which are in-house outfits at large drug makers such as Ranbaxy Laboratories Ltd, Dr Reddy’s Laboratories Ltd and Torrent Pharmaceuticals Ltd, according to data available with the National GLP Compliance Monitoring Authority set up by the department of science and technology of the Union government.
Just not enough: India has just a dozen GLP-approved labs, half of which are in-house outfits at drug makers such as Ranbaxy Laboratories and Dr Reddy’s Laboratories.
The amount of work that will eventually land at the independent labs looks daunting. A GLP-approved lab in Valsad, Gujarat, Jai Research Foundation, has identified as many as 500 unique chemical compounds from exports of just six companies whose product portfolios include drug intermediates, agro intermediates as well as other chemical substances, its director S.Y. Pandey said.
“Whether all these compounds will need testing or not will depend on Echa’s evaluation of data submitted during pre-registration period,” he said. “For those chemical compounds that need testing, depending on tonnage, best case scenario could mean 26 tests, which could take two-four years, and the worst case scenario could mean 63 tests, which could take between three and four years.”
The compliance monitoring authority issues GLP certificates to laboratories after inspections and regular audits to ensure that quality standards stipulated by OECD are adhered to.
“There has been no significant increase in the number of applications from laboratories for GLP compliance certification,” said the monitoring authority’s head R. Saha, when asked if there has been any spike in interest in getting GLP compliance in the run-up to the REACH November deadline. Inspection of labs and issuance of certificate can take between six months and two years, as the process involves unannounced inspections and continuous monitoring.
There are only a handful of new labs whose applications are currently being processed by the compliance monitoring authority. In effect, this rules out the possibility of a sudden increase in number of GLP - approved labs in the near future. Further, a GLP compliance certificate is valid only for three years and will need to be renewed after that.
The in-house labs at pharmaceutical firms are unlikely to be available for such testing. “These in-house labs are not commercial entities catering to outside clients but are primarily meant to meet the internal research and development needs,” said Reynold D’Souza, chairman of the Indian Chemical Council’s expert committee on REACH.
On 12 May, Mint reported that Indian drugs and chemical exporters to the EU were ill-prepared for the 30 November deadline, and several such firms were not even aware of the process to comply with pre-registration for REACH.
During the REACH pre-registration period from 1 June to 30 November, manufacturers and importers of chemical substances have to submit currently available data about their products to the agency.
“Following preliminary evaluation, (the agency) will determine which chemical substances need detailed chemical safety reports that will require additional tests,” said Shrirang Bhoot, senior researcher at the Network for Preventive Environment Management, a public trust that is collaborating with the EU to provide REACH support in India. The deadline for submitting chemical safety reports depends on the quantity of chemicals exported. Manufacturers exporting more than 1,000 tonnes per year have a deadline of November 2010, while for substances exported in quantities of over 100 tonnes but less than 1,000 tonnes a year, the chemical safety reports must be submitted by May 2013.