The union health ministry will soon amend Rule 122 (E) of the Drugs and Cosmetics Rules, 1945 to include new drug delivery systems including modified release dosage forms of drug formulation as new drug.

The ministry's highest decision-making body on technical matters, the Drugs Technical Advisory Board (DTAB) in its meeting held on November 25 last year gave its green signal for a proposal to this effect by the health ministry.

In the DTAB meeting, drugs controller general of India Dr GN Singh, who is the member secretary of the Board, explained to the members that the task force set up by the ministry of health and family welfare, for the purpose of formulating a long term policy for strengthening the drug sector, under the chairmanship of Dr V M Katoch, secretary, DHR, and DG, ICMR recommended that each new drug delivery system including modified release dosage form 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 a new drug.

The controlled release formulations of a drug are reported to be vastly different from each other with respect to their efficacy and toxicity. Composition as well as the process of manufacture of the carrier of the controlled release formulations has an impact on the clinical performance of active pharmaceutical ingredient in the controlled release formulation.

It was therefore proposed that the explanation under rule 122 (E) of D&C Rules needs to be amended so that it covers all new drug delivery system including modified release dosage form of the drugs as new drugs along with all vaccines, recombinant DNA (r-DNA) derived drugs as under. “All vaccines, recombinant DNA (r-DNA) derived drugs and all New Drug Delivery Systems including modified release dosage forms of a drug formulation shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21”.

The DTAB after deliberations agreed to the proposed amendment. It was, however, clarified that these applications will not be treated as Investigation New Drugs (IND) applications. CDSCO shall prepare guidelines in respect of new drug delivery systems for the information of the industry as well as regulatory authorities.

The matter was also considered in the 44th meeting of the Drugs Consultative Committee held on July 20, 2012 and the committee agreed to the proposed amendment. It however, further desired that the term 'modified release' may be defined under the rules for the purpose of clarity.