The research oriented drug companies are finding import of drugs for testing purpose a cumbersome process due to the requirement of dual approval from the central and state drug regulatory authorities. The companies suggest relaxation of dual test license requirements (central clearance through Form 11 approval and state clearance by producing Form 29) for facilitating easy import of drugs for research purposes.
According to drug industry sources, the Central Drugs Standard Control Organiastion (CDSCO) authorities are insisting upon producing Form 29 clearances from state drug authorities before issuing import licenses as per Form 11 for the purpose of examination, test or analysis of drugs. This has resulted in unnecessary delay that can be avoided through departmental instructions, they feel. Interestingly, the approval in Form 11 is necessitated by the Rules 33 & 34 made under the Drugs and Cosmetics Act.
The Rule 33 allows import of drugs for examination, test or analysis - small quantities of drugs the import of which is otherwise prohibited under Section 10 of the Act for the purpose of examination, test or analysis. The Rule states that "No drug shall be imported for such purpose except under a license in Form 11, the license shall use the substances imported under the license exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the license, or in such other places as the licensing authority may from time to time authorize.
The Rule also states that the license shall allow any inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof.
The licensee is to keep a record of and report to the licensing authority the substances imported under the license together with the quantities imported, the date of importation, and the name of the manufacturer. While there is no mention of Form 29 anywhere in Rule 33 or 34, the drug authorities are insisting upon the second approval from the State Government as per the Rule 89 in Drugs and Cosmetic Rules. The Part VIII of the D & C Rules, which includes Rule 89, deals with the regulatory requirement in terms of manufacture of drugs for examination, test or analysis. It says that if the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a license in Form 25 or Form 28 in respect of such drugs, he shall, before commencing such manufacture, obtain a license in Form 29. The application for a license in Form 29 has to be made to the state licensing authority and is to be countersigned by the head of the institution which takes up the manufacturing activity.
While the drug companies maintain that Form 29, about which there is no mention in the Rule 33, should not be a pre-requisite for import sanctions of small quantity of drugs, the CDSCO officials are calling for Form 29 in the case of all import applications that involve more than a kilogram of the drug. The drug companies feel that the One Kg limit is not logical in the changed situations where the companies have to produce at least 'one lakh units' of generic equivalent before agencies like US FDA or UK MCA for convincing them of the stability of the product.
"Indian companies are interested in importing all new drugs that are introduced in the international market. It is only after studying these drugs we will be able to begin working on improvements, or changes so as to file NDDS applications in developed countries. The manufacturing activity for test purposes cannot be restricted by use of one Kg as it is developed as per the requirement of international agencies. Since these drugs are not available or approved in Indian market, there is no question of drugs being misused in local market. Why cannot the drug authorities bring in some procedural changes to make test licensing a central business rather than ask the companies to run for state approval, thereby delaying our import approvals unnecessarily," they ask.
Most of the Indian companies that are applying for test licenses today are aiming at developing generic equivalents for exports. They feel that the drug regulators should realise the highly competitive nature of drug R&D and help them ease the hurdles before receiving import sanctions. On the other hand, the drug authorities want to be on the safer side, and are insisting upon both central and state approvals for such drugs.