Question : PHARMACEUTICAL UNITS



(a) the number of pharmaceutical units in the country, State-wise;

(b) the number of units out of these have been registered under the Small Scale Industries;

(c) the number of times approximately the quality control tests of the medicines manufactured by these units have been conducted during the last three years; and

(d) the details of action taken against the manufacturers manufacturing sub-standard medicines alongwith their details and manufacturing the names of such drugs, State-wise?

Answer given by the minister

THE MINISTER OF STATE IN THE MINISTRY OF CHEMICALS & FERTILIZERS (SHRI S.B. MOOKHERJEE)

(a) & (b): A large number of pharmaceutical units both in the organised sector and in the small scale sector are operating in the country. State-wise break up of these units is not centrally maintained. There is no central registration system for small-scale sector. The small-scale units are being registered by their respective State Directorate of Industries.

(c): Under the provisions of Drugs and Cosmetics Act 1940 and Rules thereunder, the State Govts. have been empowered to enforce quality of drugs including monitoring of manufacture, sale and distribution of drugs. The enforcement of quality control of drugs and pharmaceuticals is regulated by a system of licensing by the State Govts. As per information available from the State Licensing Authorities, the number of samples tested for quality during the period 1997-98 to 1999-2000 is given below:

Year Samples 
1997-98 32936 1998-99 38936 1999-2000 35570


(d): Information to the extent available from the State Licensing Authorities is given in Annexure.