Lab norms to hit small drug firms

With the government planning to make Good Laboratory Practice (GLP) norms mandatory, around 5,000 small scale drug manufacturers would be compelled to make substantial investments in setting up or upgrading quality assurance (QA) facilities, if they are to continue in business.

Small scale drug makers fear that they may have to shell out anything between Rs 20 lakh to Rs one crore for acquiring land and equipment as mandated by the new GLP.

The GLP is the second major regulatory intervention after the announcement of the comprehensive Good Manufacturing Practice (GMP) norms a couple of years ago.

Though the GMP called for an in-house testing facility, SSI units were allowed to outsource the work from independent drug testing laboratories.

However, the current GLP notification proposes inclusion of all in-house laboratories.

"The GLP norms should be applicable only to standalone drug testing laboratories. In-house facilities of SSI units should be out of its purview," TS Jaishankar, chairman, Confederation of Indian Pharmaceutical Industries (SSI) said.

According to Jagdeep Singh, president, Punjab Drug Manufacturers Association, "We are willing to upgrade, but we are yet to overcome the troubles caused by the revised GMP. With the GLP calling for fresh stipulations for premises and equipment, we will find it extremely difficult to upgrade ourselves in a short notice."

The government has already issued a draft notification that proposes an amendment to Drugs and Cosmetics Rules to provide specific instructions for the maintenance of laboratories and spell out the requirements of premises and equipment.

The draft GLP talks about the upkeep of animal houses, qualifications of the personnel, safety rules, land requirement, among others.

It should be noted that the chemicals ministry had long back stressed the need for an interest subsidy scheme for SSI drug makers to help them comply with the GMP norms.

While the assistance scheme remains on paper, official figures indicate that over 700 SSI drug units have either closed down or are on the verge of closure owing to non-compliance of the revised GMP norms.