GOVERNMENT OF INDIA

Ministry of Health and Family Welfare

DEPARTMENT OF HEALTH AND FAMILY WELFARE

RAJYASABHA
STARRED QUESTION NO. 334
TO BE ANSWERED ON 17TH AUGUST, 2010
Sale of Sub-Standard Drugs in Delhi

* 334. SHRI RAJEEV CHANDRASEKHAR:

Will the Minister of HEALTH AND F AMIL Y WELFARE be pleased to state:

(a) whether Government is aware of a recent study by an NGO stating that 12 per cent of the drugs purchased from Pharmacies in Delhi are sub­standard or spurious;

(b) if so, whether Government has been able to identify the culprits in this regard;

(c) if so, the details thereof; and

(d) the steps Government proposes to take to address this issue and ensure access to safe and secure medicines for people?

ANSWER

THE MINISTER OF HEALTH AND FAMILY WELFARE

(SHRI GHULAM NABI AZAD)

(a) to (d): A statement is laid on the Table of the House.

STATEMENT REFERRED TO IN REPLY TO RAJYA SABHA

STARRED QUESTION NO. 334 FOR 17^TH AUGUST, 2010

(a) Government has come across a news item published in ‘The Wall Street Journal’ date May 19, 2010, wherein it was mentioned that Mr. Roger Bate, the author of the article had conducted certain surveys in Delhi and Chennai in 2009 wherein five medicines sold at 52 different pharmacies were analysed and whereupon 12 percent of the medicines in Delhi were found sub- standard.

(b) & (c): The Drugs Control Department of Government of Delhi has informed that they are not aaware of any such study as published in the said news paper. The report did not mention the names of the drugs analyzed or the names and addresses of the pharmacies from wehre samples were drawn as well as the authority which declared them as not of standard quality.

(d): The following steps have been taken by the Government to check the problem of spurious drugs in the country-

1. The Drugs and Cosmetics Act, 1940, has been amended under Drugs & Cosmetics (Amendment) Act, 2008, and it has come in to force since 10^th Aug, 2009. Penalty for manufacture of spurious & adulterated drugs has been enhanced to an imprisonment for not less than 10 years but which may extend to for life and shall also be liable to fine which shall not be less than 10 lakh rupees or three times the value of the drugs confiscated whichever is more. Certain offences have been made cognizable and non- bailable.

2. State Governments have been requested to set up special courts to try cases of spurious and adulterated drugs.

Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008, has been prepared and forwarded to the State Drug Controllers for implementation.

4. Whistle Blower Scheme has been announced by Government of India to encourage vigilant public participation in the detection of movement of spurious drugs in the country. Under this policy, the informers would be suitable rewarded for providing concrete information in respect of movement of spurious drugs to the regulatory authorities.

5. Schedule M to the Drugs and Cosmetics Rules, 1945, pertaining to Good Manufacturing Practices was amended to make it at par with the international standards. It is mandatory for the manufacturers of drugs to comply with the requirements of this Schedule for quality control of the drugs manufactured by them.