A request to this effect had been made by the Indian Drug Manufacturers Association (IDMA) to enable shipments already on the way to India to be cleared without registration.
Under a notification issued last year by the ministry of health and family welfare, the manufacturing premises of foreign drug manufacturers and the individual drugs had to be registered. The notification is due to be operational from January 1, 2003.
The IDMA had sought clarification from the DCGI if goods shipped before December 31, 2002 but landing after January 1, 2003 would be exempt from this registration. The latter had earlier stated that the same would be considered on a case to case basis, followed by a categorical No sometime later. Sources said the DCGI Ashwini Kumar had finally agreed for a three-month extension after repeated requests from industry, to be notified on the next working day.
An IDMA spokeperson told FE that the association supported the registration of imported drugs in principle to keep the marketplace free from sub-standard and spurious goods being imported from countries like China. Application for registration can be made by authorised agents of the manufacturers in India. Further, according to these new rules, import licence will be required for all types of drugs instead of only schedule C and C(1) and schedule X drugs currently.
The rules also allow for inspection of the facilities of a foreign manufacturing facility by the Indian drug authorities for a fee of $5,000 (Rs 2.5 lakhs). A fee of $1,500 (Rs 75,000) and $1,000 (Rs 50,000) will be charged for registration of overseas manufacturers premises and every individual drug respectively.
The authorities had advised all manufacturers and importers to obtain registration certificates before March 31 and import licences by September 30 to provide for enough lead time for applications to be processed. These registration requirements are similar to practices being followed in many other countries, affecting Indian manufacturers exporting overseas too.
Another fear expressed by the industry was the possibility of a shortage of certain drugs in the market where the manufacturers were either not responding to the new requirments or were being slow in doing so. The DCGI expressed confidence there were sufficient buffer stocks in the country to prevent shortages or sharp rise in prices. But should such a situation arise, registration rules may be relaxed on a case to case basis.