The Central Drugs Standard Control Organisation (CDSCO) is planning to amend the rules to include modified release form of drug formulation as a new drug and also to define the term 'modified release', in line with the recommendations of an expert panel.
A Task Force was set up by the Ministry of Health and Family Welfare for the purpose of formulating a long term policy for strengthening the drug sector. A sub-group under the chairmanship of Dr V M Katoch, secretary, HR, and DG, ICMR recommended in its report that the Controlled Release Formulations of the same drug are reported to be vastly different from each other with respect to their efficacy as well as toxicity.
“Composition as well as the process of manufacture of the carrier controlled release formulations has impact on the clinical performance of Active Pharmaceutical Ingredient (API) in the controlled release formulation. Therefore each controlled release formulation whether a copy of a studied and approved drug or another one should be treated as a new drug and accordingly subjected to the requirement of complete studies as new drug. This practice is followed internationally. Any deviation from this norm is being observed globally as to allow sub-par performer formulations in the name of generics,” according to the expert panel.
The move is to amend the explanation under rule 122 (E) of Drugs and Cosmetics Rules so that it covers all modified release dosage form of the drugs as new drugs along with all vaccines, recombinant DNA (r-DNA) derived drugs. The proposal also got the approval from the Drug Consultative Committee (DCC) which recommended for defining the term 'modified release'.
Accordingly, the rule will be amended to include explanation that “all vaccines, recombinant DNA (r-DNA) derived drugs and all modified release form of drug formulations shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21.”
The existing rule says that “all vaccines and recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21.”