The Prof. Ranjit Roy Chaudhury expert committee, constituted by the union health ministry to formulate policy, guidelines and SOPs for approval of new drugs including biologicals, clinical trials and banning of drugs, has recommended that bioavailability (BA) and bioequivalence (BE) studies of new drug substances discovered abroad and not marketed in India should not be approved to be conducted in India.

If new chemical entities (NCEs), new drug substances or their generic drugs are to be introduced in India, BA/BE studies in patients should be done as a part of the clinical trials, the panel in its recommendations said.

However, the expert committee recommended that a generic drug produced in India for the first time should undergo BE studies in comparison with the innovator molecule. The subsequent generics of the same drug (i.e. the same active pharmaceutical ingredient) showing good absorption orally (i.e. high solubility and high permeability) and similar in vitro release rate need not undergo BA and BE studies. They should be cleared based on data from recommended methods for determining solubility, permeability and in vitro dissolution using the innovator molecule for comparison, it further said.

In its sweeping changes recommended for approval of new drugs including biologicals, the committee recommended that biowaivers will be permitted for in vivo BA and BE studies in cases of high solubility and low permeability immediate-release solid oral-dosage forms.

The committee, constituted by the government in February this year, also recommended that India should participate in global clinical trials of NCEs to be used for diseases that are prevalent in our population. BA studies including pharmacokinetic and pharmacodynamic studies should also be conducted on the Indian population. After approval for marketing in the innovator country or in well-regulated developed country markets, approval should be sought from the DCGI for marketing these NCEs in India. After approval by the DCGI, these NCEs should be marketed in India speedily, preferably by production within the country. Ethnic and tribal population trials should be conducted before prescribing the NCE for such population groups.