Under Rule 12 of this regulation, no establishment is permitted to ``contract or undertake to perform contract research or experiments.'' This means that a global or Indian company or a foreign institute cannot enter into a contract or collaborative research, involving animals, with the Indian industry or other academic research institutions. This, accordingto Nicholas Piramal chief scientific officer, Dr Swati Piramal, not only prevents R&D organisations from boosting earnings to support their activities but also effectively shuts the door to accessing knowledge and knowhow via collaborative efforts.

In a note to the newly formed committee, Nicholas Piramal has said under these conditions, the industry would have no other choice but to contract this work to international organisations.

The BEA rules also disallow free imports of transgenic animals, genetic strains that develop specific diseases etc, a vital component in drug discovery research. Such imports are currently subject to unwarranted regulatory and other bureaucratic procedures, which lead to a loss in valuable time in taking R&D projects further, the note adds. Dr Reddy's Laboratories' request for obese mice for experiments was reportedly disallowed, while the Delhi-based Ranbaxy also faced similar trouble with the import of dogs.

Says Sun Pharma managing director Dilip Shanghvi, ``Transgenicbreeds of animals allow you to test leads on specific animal models - there are other markers but they are not infallible. This is also the quickest way. If such work is not allowed in India, it would have to be done through a contract research organisation or one would have to look beyond India.''

Interestingly, BEA Rule number 9 (A) stipulates that animal experiments can only be conducted by or under the supervision of a degree or diploma holder of veterinary science, medicine or laboratory animal science of any recognised university. This, industry experts say, is illogical given that it excludes professionals with degrees in pharmacy, pharmacology, biochemistry, cell biology, microbiology, etc, from doing animal research.

Adds Shanghvi, ``For animal experiments, you would need to have people with specific training and skills in that area. For instance if you were studying cell structure, you would need a molecular biologist or pharmacologist. Even vets do not have the knowledge base or the expertiseyou require for very specific skilled experiments.'' Unless the government moves quickly, the drug industry may lose out in the race to build its drug reservoir.