The Union health ministry will soon increase the validity of the licence to import drugs for test and analysis under Form 11 and licence to manufacture drugs for test and analysis under Form 29 from one year to three years.
Under the Rule 33 of the Drugs and Cosmetics Rules, 1945, small quantities of drugs, the import of which is otherwise prohibited under the Act, are permitted to be imported for the purpose of examination, test and analysis in Form 11. The Form under serial number 3 provides the validity period of one year from the date of issue stated in the Form. Similarly licence to manufactured drugs for the purpose of examination, test or analysis is granted in Form 29 under Rule 89 of the said rules. Here also the validity of the licence is for one year from the date of issue.
For quite some time, health ministry has been receiving representations from various drug manufacturers associations that for the purpose of clinical trials and drug development, the licencees have to approach the licensing authorities for grant of fresh licence every year. It will go a long way in ease of doing business, if the Ministry extends the validity of licences in Form 11 & Form 29 from one year to three years, the associations argued. Besides, the department of commerce has also recommended in the various meetings to increase the validity of these licences from one year to three years for creation ease of business in the vital sector of clinical trials and drug development.
The issue came up for discussion during the 70th meeting of Drugs Technical Advisory Board (DTAB) held on August 18, 2015 at CDSCO, New Delhi. DTAB is the highest authority under the Union health ministry on technical matters.
After detailed discussions, the DTAB agreed to the proposed recommendations that the validity of the licences in Form 11 and Form 29 to be increased from one year to three years.