The Union health ministry is likely to relax rules on Bioavailability or Bioequivalence (BA/BE) studies in respect of drugs manufactured in the country.

According to sources, the Drugs Consultative Committee (DCC) of the Union health ministry, which comprises all the state drug controllers besides senior health ministry officials including the DCGI, has recommended to the ministry that BA/BE studies in respect of drugs manufactured in the country should be insisted whenever there are issues relating to patient safety and variable bioavailability.  “As the infrastructure for conduct of such studies is not uniformly available in the country, it cannot be implemented as a rule”, the DCC recommended.

In the case of BA/BE studies for export purposes such studies may be permitted as per requirements. The growth of the Indian pharma industry in terms of exports is declining in the last few years and any embargo on BA/BE studies on substances discovered abroad and not marketed in India would further decline the exports. This would ultimately impact the research and drug development in the country. In the interest of human safety, the permission for the study may not be granted in case the well being of the trial subjects is endangered, the DCC in its meeting held recently recommended to the ministry. It however, agreed that in the case drugs which are banned in the country for marketing, the BA/BE studies should not be permitted.

The DCC recommendations will now be taken up by the Drugs Technical Advisory Board (DTAB), the highest authority in the union health ministry on technical matters, which is expected to take a final call on the issue.

The DCC deliberated on the recommendations of the Prof Ranjit Roy Chaudhury Committee on this issue. After detailed deliberations, the DCC asked the DTAB to consider two issues. First, the requirement of BE study for subsequent approval of new drugs already approved in the country. Presently, BE study for oral dosage form of only new drugs is required till four years of approvals of these drugs. In order to make it mandatory for all drugs other than new drugs, it would require amendment in Rules. Such a provision will also have an impact on cost, time required for grant of license, infrastructure, etc.

Second, continued permitting of (BA/BE) studies for export purpose.

Presently, BA/BE studies of drugs of foreign manufacturer or by Indian manufacturer for generating data for submission to foreign Regulatory Authority for export purposes is being carried out at many centres in the country. The continuation of such studies for export purposes is required to be deliberated in the light of the recommendations of the Committee and its impact on the pharmaceutical industry.