Leading medical experts have called for developing separate regulatory guidelines for biological generics as the existing rules designed mainly for chemical entities did not hold good for biological drugs.

``The lack of regulation has led to several forms of sub-standard copies flooding the market. This is a grave situation since most of these drugs are used in critical care and are categorized as life saving medicines,'' leading experts felt, while kicking off deliberations and moves to chalk out some guidelines for approving the biological drugs, a new potential area of growth in the country.

With this aim, the International Union of Angiology (IUA), the South Asian Society for Atherothrombosis (SASAT), International Academy of Clinical, Applied Thrombosis (ICATH) and All India Institute of Medical Sciences (AIIMS) got together to organise the first international summit on the topic here recently. Summit brought together global experts from SASAT, IUA and ICATH to discuss guidelines for the ethical development of generic medicines of biological or mixed (biological and chemical origin) like antithrombotics.

Dr Jawed Fareed, president of SASAT said the regulatory compliance guidelines from WHO, US FDA and other agencies were unclear and thus the generic versions of these drugs were not manufactured using the stringent biological and chemical controls applied to the branded products. ``This leads to sub-standard products which may affect the safety and efficacy of the drug," he cautioned.

"The problem of unregulated generics is significant to India since India is the largest generic drugs producer. There are already 14 to 15 copies of the molecule Enoxaparin, a key medication for heart attacks. In the absence of any regulatory mechanism to produce this drug it is difficult to ascertain whether all these copies are true copies or whether it would lead patients to a worse consequence of heart attack", Dr Ashok Seth, chairman and chief cardiologist, Max Heart & Vascular Institute said.

Dr Gundu Rao, Professor, University of Minnesota Medical School, USA, said, "The lack of regulation has led to the development and introduction of several generic anti-thrombotic drugs globally, however some of them had to be withdrawn after initial approval to avoid patient care adverse-related issues.''

The experts said that the regulatory guidelines for copies of chemical drugs cannot be applied to biological drugs. A comparison of Low Molecular Weight Heparins (LMWH) and branded versions has shown noticeable pharmacological difference despite chemical equivalence amongst some of the products. In a comparative study, 21 samples of generic streptokinase were tested and only three samples were found to perform as per the information listed on the label. This striking discrepancy between claimed and actual performance of these critical drugs may result in life threatening situations for critically ill patients, they pointed out.