The Union health ministry will soon issue guidelines to facilitate the ease of business in respect of the procedures for registration and import licence under the Drugs and Cosmetics Rules, 1945. Besides, the ministry may raise the fees for import registration in the country from Rs. one lakh to Rs. five lakh.
The import of drugs is regulated under the system of registration and import licence under the Drugs and Cosmetics Rules, 1945. The manufacturers who intend to export drugs to India are required to have registration certificate to ensure that drugs from only authentic sources are permitted in the country. The drugs are imported under the import licences granted to the importers.
But there were concerns among the importers about the bottlenecks faced by Indian agents, manufacturers and exporters because of lack of guidelines in respect of various issues like fees to be charged, change of letters, requirements of documents, etc.
The ministry of commerce had also requested that necessary guidelines may be issued to address the difficulties of the importers of drugs and creating ease of business in pharma sector.
The Union health ministry then prepared the guidelines proposed to be followed to facilitate ease of business in respect of the procedures for registration and import licence under the Drugs and Cosmetics Rules, 1945. The ministry then asked the DTAB to deliberate on the issue.
As per the guidelines, the fee for fresh registration certificate should not be insisted upon the case there is only a change of address of the registered office of the manufacturer abroad or his Indian agent as these changes do not impact the quality or the manufacturing site.
The guidelines further say that import licence may be granted at the address of the importers as mentioned in the wholesale licence or manufacturing licence. The licence may however, be dispatched to the registered office of the importer if required. The address of the wholesale licence shall also be mentioned on the licence where physical transaction of the material will take place.
As per the guidelines, the products which are considered as drugs in India but are licensed as food products or excipients in other countries are not regulated as drugs and as such do not have good manufacturing practices certificates or free sale certificate in the country of origin. Such products may be approved on the basis of equivalent/alternative certificate provided such certificates have been issued on the basis of the inspection. The products at the time of import may be subjected to test to ensure its quality.
After detailed deliberations, the DTAB gave its green signal for the guidelines. It, however, further recommended that fees for import registration in the country should be increased from one lakhs rupees to five lakhs rupees.