The Drug Controller General of India (DCGI) may shortly form an expert committee for conducting physical inspection of the drug manufacturing facilities abroad for the purpose of import registration of drugs and sourcing companies.
Though it has been proposed by the pharmaceutical industry associations ever since the new import registration norms were notified by the Union Ministry of Health and Family Welfare in August, 2001, the Department could not take any steps in this regard as there was already a shortage of staff for any additional assignment within the Central Drugs Standard Control Organization (CDSCO).
However, the Department is learnt to have initiated the process of constituting a small group of experts, who are competent for inspection of manufacturing facilities, from within and outside the Department. The experts who would be assigned to the committee from outside the Department are likely to be industry representatives suggested by the industry associations and major drug import organizations.
With no special team to conduct physical verification of the drug importing sites for the registration so far, the Department has been clearing the applications for import registration only with the verification of documents submitted by the exporters from abroad either directly or through their agents in India. Till December 15, 2002, the DCGI office has registered 312 drugs and 187 manufacturing facilities for imports into the country.
The Union Health Ministry had published a Gazette Notification GSR no. 604 (E) dated 24.08.2001 amending the various provisions of the Drugs & Cosmetics Rules, thereby introducing a new provision for the registration of the manufacturing premises of foreign drug manufacturer and the individual drugs prior to their import into the country. The notification has also introduced few other provisions viz. enhanced import licence fees, increased validity period of licence, deletion of exemption from requirement of import licence for bulk drugs for actual users, requirement of minimum 60 per cent of retained shelf life for imported drugs and provisions for import of small quantities of new drugs by government hospitals for treatment of their own patients etc.
Under the new dispensation, foreign manufacturers have to apply for registration certificate for their manufacturing premises and the individual drugs to be imported. Authorized agents of foreign firms in India can make the applications. The documents required for registration certificates have been clearly specified in the amendments. The validity of registration certificates will be three years from the date on which these are issued. A fee of 1500 USD is to be charged for the registration of overseas manufacturer's premises and fee of 1000 USD will be charged for every individual drug. The rules provide now for inspection of the premises of a foreign manufacturer by Indian Drug Authorities, whenever so required. In such cases, an additional fee of 5000 USD is to be charged. The rules also provided for payment of testing charges by registration holders. The foreign manufacturer or his authorised agent in India shall be liable to report any change in the manufacturing and testing process of a drug.
However, no registration certificate shall be insisted in respect of an inactive bulk substance to be used as pharmaceutical aid for manufacture of drug formulation. The registration may be suspended or cancelled in the event any violation of the conditions for registration comes to notice. The new registration and import licence scheme shall also cover diagnostic kits viz. HIV I & II, HBsAg, HCV and blood group reagents.
According to new rules, import licence will be required for all types of drugs instead of existing import licence requirements for Schedule C & C (1) and Schedule X drugs only. Import licence in Form 10 would be granted after completing the registration of overseas manufacturers and their specific drugs to be imported. The import licence for specific drugs will be valid for 3 years from the date on which these are granted. The import licence fee has been kept Rs. 1000/- for a single drug and at the rate of Rs.100/- for additional drug. The fee of import licences for test and analysis of a drug has been kept Rs. 100/- for a single drug and at the rate of Rs. 50/- for each additional drug. The exemption from import licences for the import of bulk drugs by the formulations for actual use under Schedule D has been deleted. A provision has been made those only drugs with minimum 60 per cent of retained shelf life shall be allowed to be imported in the country.
A separate provision has been made to enable the Govt. hospitals to import small quantities of essential new drugs for the treatment of their own patients. The fee for such import licences has been kept Rs. 100/- for a single drug and the rate of Rs. 50/- for each additional drug.
Click here to view table showing listing of drugs, finished formulations alongwith their manufacturing sites and Indian authorized agents registered for imports till 15th December, 2002
Click here to view table showing listing of registration certificates issued for bulk drugs alongwith their manufacturing sites and Indian authorized agents till 15th December, 2002