CUSTOMS INSTRUCTION DATE 22/01/2007

Import of drugs under Chemical or generic name - Regarding.
The undersigned is directed to refer to the above subject and to say that the Drugs Controller General (I), Directorate General of Health Services, has intimated that the Central Drug Standard Control Organization (CDSCO) is responsible for monitoring the quality of medicines manufactured, distributed, sold and imported into the country as per the provisions of the Drugs and Cosmetics (D&C) Act and Rules made thereunder. Chapter 3 of the Drugs and Cosmetics Act, 1940 deals with the control over drugs and cosmetics imported into the country. In order to have control over the quality of drugs, the D&C Act restricts the port entries for drugs under Rule 43 of D&C Rules. It has been requested that the services of the officers of the Ministry of Health and FW posted at the port/ airport be utilized to ensure quality of the imported products.

2. As per rule 43A of the Drugs and Cosmetics Rules, 1945, drugs can be imported into India through one of the following places, namely: __

(i) Freozepore Cantonment and Amritsar Railway Stations (in respect of drugs imported by rail across the frontier with Pakistan)

(ii) Ranaghat, Bongaon and Mohiassan Railways Stations (in respect of drugs imported by rail across the frontier with Bangladesh)

(iii) Raxaul (in respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal)

(iv) Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva and Kandla (in respect of drugs imported by sea into India)

(v) Chennai, Kolkata, Mumbai, Delhi, Ahmedabad and Hyderabad (in respect of drugs imported by airports into India)

3. Accordingly, import of drugs at the ports other than those mentioned above, may not be permitted as per the provisions of the Drugs and Cosmetics Rules, 1945. Further, whenever in doubt, field formations may seek necessary clarification about the generic name versus chemical name of medicines before clearance.

F.No. 450/08/2007-Cus.IV

Yours faithfully,

(Anupam Prakash)
Under Secretary to the Government of India
Phone No.23094182

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