The Drugs Technical Advisory Board (DTAB) has approved the Union health ministry’s recent proposal to amend the Drugs and Cosmetics Rules, 1945 for upward revision of fees charged of various licensing activities under the Rules. However, the quantum of increase may be decided by the government in consultation with the stakeholders.
The issue came up for discussion in the DTAB’s 71st meeting held on May 13, 2016. In the meeting, the members were briefed that the Drugs and Cosmetics Rules, 1945 specify various fees to be charged for various categories of licenses or permissions granted under the said rules.
These permissions include grant of registration certificate and import licences for the import of drugs and medical devices, permissions for clinical trials and import of drugs for test, analysis and overseas inspections by the CDSCO. Fees are also charged for various manufacturing and sale licences granted by the State Licensing Authorities.
The present fees were last upgraded in 2001 and 2003 only. The revision of fees was therefore considered necessary as the current fees were not upgraded since last thirteen years or so. Accordingly, the health ministry published the draft rules for comments from the public vide G.S.R. 1011 (E) dated 29.12.2015 without consultation of DTAB whereas the central government proposed to consult the DTAB within six months of from the date of publication of these rules.
In the meeting, the members were also informed that the upward revision of the fees was necessitated because of the several factors. In the 12th Five Year Plan, Drug Regulatory mechanism in terms of infrastructure; both physical and human resources at the Centre and the states is being strengthened.
CDSCO is being strengthened by setting up of new offices, enhancing the drugs testing capacity, human resources development, introduction of E-governance etc. These activities, however, necessitate exploration of more avenues for revenue generation and review of the existing fee structure etc. for achieving self sufficiency.
The members were also informed that the cost of the registration in India is extremely low as compared to other countries. Concerns have been expressed over the import of Active Pharmaceutical Ingredients (APls) from China which is over 60 per cent of the total API requirement of the country. In India registration per product costs about $1000 while similar registration costs about $35,000 per product in China. This is having impact on Indian bulk drug industry.
The fees charged for grant of various manufacturing and sale licence by the state remained constant for well over ten years. This despite the fact that cost index in the country as increased manifold. DTAB after deliberations agreed that in principle the fees are required to be raised for providing services under the rules. The quantum of increase may however be decided by the government in consultation with the stakeholders.