Question : INFLOW OF BANNED DRUGS IN HOSPITALS

(a) whether the attention of the Government has been drawn to the news-item captioned `Inflow of banned drugs by Multi-National Companies` appearing in the `Rashtriya Sahara` dated April 2, 2002;

(b) if so, the facts of the matter reported therein alongwith the reaction of the Government thereto;

(c) whether the multi-national companies are doing so because of flexibility and loopholes in the India laws;

(d) whether the Government are considering to amend the relevant laws to check the inflow of banned drugs by the multi-national companies;

(e) whether the Government propose to enact a stringent law in this regard;

(f) if so, the time by which the amendment is likely to be made; and

(g) if not, the reasons therefor?

MINISTER OF HEALTH AND FAMILY WELFARE (DR. C.P. THAKUR)

(a) to (g): A statement is laid on the Table of the Lok Sabha.


STATEMENT REFERRED TO IN REPLY TO THE LOK SABHA STARRED QUESTION NO. 611 FOR 8TH MAY 2002


Yes, Sir. The office of DCG(I) has not received any complaint/report that the drugs which are banned/prohibited in the developed countries are in use or experimented on patients by the multinational companies in the Government or Private hospitals of Delhi as alleged in the news item. The Department of Health and Family Welfare, Government of NCT of Delhi, has informed that no meeting was taken by Smt. Adarsh Mishra, the then Principal Secretary(H) nor any direction was given to the Director Health Services, Dr. R.N. Vaisya, as stated in the news report.

Drugs like Septran (Co-Trimaxazole), Ciprobid (Ciprofloxacin), Enaten (Enalapril), Paracetamol etc. are old established drugs and manufactured by large number of Indian and Multinational Companies. It is mandatory under Drugs and Cosmetics Rules that every batch of a drug formulation is marketed only after testing of its quality specification. The statement in the news report that these drugs are marketed by various companies without testing is, therefore, not true.

The matter regarding import of drugs by a Phillippine company relates to labelling provisions. The distribution of these products was immediately stopped and the firm was directed to provide all information on the labels as per the domestic norms. The Assistant Drugs Controller (India), I.G.I., Airport, New Delhi, was instructed to ensure that prescribed labelling requirements are complied with before release of goods.

There is no flexibility or loophole in the Drugs and Cosmetics Act and Rules made thereunder, which may result in possible sale of banned drugs. Section 26(A) of the Act empowers the Central Government to prohibit manufacture and sale of drugs and cosmetics in public interest. Any sale of banned drugs would attract the penal provisions of Section 28(b) under the Act. Since adequate provision exists for prohibiting the import, manufacture and sale of a drug found hazardous or irrational, the question of amending the law does not arise.