The Health Ministry is planning to review the scope, conditions and fee structure of licences to manufacture drugs for tests and analysis and also thinking to increase the present validity of the licence from one year to three years.
The proposal has reportedly been discussed by the Drugs Consultative Committee (DCC) at its last meeting, after some States took up the issue in the backdrop of the growing number of contract research organizations and testing facilities.
The DCC agreed in principle that the scope, the conditions and fees etc. for license in Form 29 should be enhanced. The validity period of such a licence may also be increased to three years against the present period of one year, sources said, adding that the detailed proposal for the amendment would be taken up at the next meeting of the panel.
It was pointed out that there was a need to fill the gaps in the licensing process under Form-29, like prescribing fees for inspection, defining test/analysis, clarification on whether BA/BE studies fall under the said definition, if compliance of schedule M by the licensee for drugs meant for clinical studies, meaning of small quantity of drugs under Form – 29.
At present, the licence to manufacture the drugs for the purpose of examination, test or analysis is prescribed under Drugs and Cosmetics Rules, 1945 in Form – 29, vide Rule 89. However, the rules at present do define terms like tests, analysis, and examination. Clarification also is missing whether the licence should include BA/BE studies.
The rules also do not speak about the number of items to be allowed under the licence. Nothing was also specified about the additional items and fee. “These days, many research and development centres are applying for test license by depositing Rs.250 as licence fee accompanying list of about 100 items or more,” one member of the DCC pointed out at the meeting.
The licence in Form 29 is granted for the validity period of one year. Generally the products which are developed are having shelf life of two-three years (for formulation) and generally five years for API’s. Stability is to be monitored for at least two to four years after manufacturing the formulation, the meeting was told.