Registration of Imported Drug

New Delhi February 22, 2014:- Drugs, irrespective of their patent status, imported into the country are regulated by the office of Drug Controller General (India) under the provisions of the Drugs and Cosmetics Act, 1940 the Drugs and Cosmetics Rules, 1945 made thereunder, through the system of registration and import licenses. The criteria and procedure for grant of registration certificate of imported drugs and approval for marketing of new drugs have been prescribed under the Drugs and Cosmetics Rules, 1945.  

 

For the purpose of grant of Registration Certificates, the manufacturer abroad or his agent in India is required to make application to the office of Drug Controller General (India) in Form-40 along with specified fees, Power of Attorney in favour of the agent in India and the information and undertakings as specified in Schedule D(I) and D(II) of the said Rules duly signed by or on behalf of the manufacturer. Thereafter, the importer is required to obtain the import licence from the said authority for the import of the drugs registered for import.

 

For the purpose of import of newly introduced drugs i.e., new drugs, prior permission is required to be obtained from the office of the Drug Controller General (India) for marketing the drug in the country. The applicant is required to submit application in form-44 along with specified fees and technical data in respect of safety and efficacy of the drug for grant of permission to import the new drug into the country. The applicant is then required to get the drug registered for import in to the country.

 

The Central Drugs Standard Control Organisation (CDSCO) has detected the following cases of import of drugs from unregistered sources from China, which were handed over to CBI for investigations:

 

1.      M/s. Envee Drugs Pvt. Ltd, Gujarat.

2.      M/s. J B. Khokhani & Co, Mumbai.

3.      M/s. Sheetal Pharmaceutical, Mumbai

4.      M/s. Kawarlal& Co, and Kawarlal & Sons, Chennai

5.      M/s. Adcock Ingrahm, Bangalore

6.      M/s. Kanwarlal & Co, Chennai

7.      General Import Company (I) Pvt. Ltd., Mumbai.

8.      M/s Antonie & Becourel Organic Co., Chennai

 

Further, Good Manufacturing Practices (GMP) Certificates furnished by the following manufacturers of China were not found to be genuine, whose Registration Certificates and Import Licenses were then cancelled:

1.   M/s. Taizhou Waigaoqiao Liantong Pharmaceutical Co. Ltd., China

2.   M/s. Zhejiang Materials Industry Chemical Group Co. Ltd., China.

3.   M/s. Changshu Nanhu Industrial Chemical Factory , China.

4.   M/s. Jintan Zhongxing Pharmaceutical & Medical Co. Ltd., China.

5.   M/s. Suzhou Ausun Chemical Co. Ltd., China.

6.   M/s. Xianju Hongyan Pharmaceutical Chemicals Co. Ltd., China.

7.   M/s. Yanshi Shuda Medicine & Chemical Co. Ltd., China.

8.   M/s. Changzhou Kangrui Chemical Co. Ltd., Ch   ina.

9.   M/s. Ningbo Double Sun Pharmaceutical Co. Ltd., China.

10. M/s. Chongquing Chunrui Medicine Chemical Co. Ltd., China

11.  M/s. Suzhou Dawnray’s Pharmaceutical Co. Ltd., China

 

The Government has not received any report regarding certain multinational drug companies have warned Indian generic drug manufacturers to stop supplying drugs meant for treating various chronic diseases.

 

This was stated by Shri Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Lok Sabha today.