Lok Sabha Question No. 3298 (UNSTARRED), answered on 2015-12-18
Subject: Safety of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: PREM DAS RAI, SANJAY JAISWAL, RANGASWAMY DHRUVANARAYANA, K. KAMARAAJ

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 3298 TO BE ANSWERED ON 18 TH DECEMBER, 2015

## SAFETY OF DRUGS

## 3298. SHRI PREM DAS RAI: DR. SANJAY JAISWAL: SHRI R. DHRUVA NARAYANA: DR. K. KAMARAJ :

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether use of untested liposomal amphotericin B reportedly poses a threat to life of and if so, the details thereof along with the corrective measures being taken by the Government in this regard;
- (b) whether certain approved fixed dose combinations of drugs are reportedly unsafe an recommended internationally, if so, the details thereof along with the reasons for their roval and the remedial steps being taken by the Government to test/screen all drug combinati order to ensure their safety;
- (c) whether the Government proposes to introduce a centralized prescription drug system can serve as a valuable inv stigative and preventive for the health care community, regulato boards and law enforcement and if so, the details thereof;
- (d) the other steps taken/proposed to be taken by the Government to ensure safety and st of drugs; and
- (e) the measu res taken/proposed to be taken by the Government to avoid misappropriation supply of drugs and the action taken against the offenders in this regard during the l years?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE

## (SHRI JAGAT PRAKASH NADDA)

- (a): Any untested drug poses risk to patients and liposomal amphotericin B is no except As per Drugs and Cosmetics Act, 1940 and Rules, 1945 thereunder, manufacturers are requir to test each batch of the drugs either in their own laboratory or i n any laboratory approved by the Licensing Authority.

Contd………

(b): New  Drugs  including  Fixed  Dose  Combinations  (FDCs)  are  approved  as  per  the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder . How ver, some FDCs considered as New Drugs under the Drugs & Cosmetics Rules, 1945 for which approval of the Drugs Controller General (India), is required, have been manufactured and marketed the approval of the State Drug Controllers / Regulators. DCG (I) had on 15.01.2013 requested all State Drugs Controllers to ask the concerned manufacturers to prove the safety and e of such FDCs before CDSCO within a period of 18 months. Notices had been issued to al manufacturers of such FDCs and the re sponses received from them have been analysed by a Committee of experts, which has submitted its report to the Government. Action as per dec taken by the Government has been initiated in respect of all such cases except 294 FDCs matter relating t o which is currently sub -judice in the Hon'ble High Court at Chennai.

(c): No such proposal is under consideration of the Government at present.

(d): For evaluation of the safety and efficacy of New Drugs, the Government has approv 25 panels  of  experts  of  various  therapeutic  areas.  Further,  Pharmacovigilance  Programm India has been launched on 14.07.2010  for monitoring, recording and reporting of Adverse Reactions (ADRs) in the country.

(e): No case of misappropriation in the supply of drugs has been reported during the last three years in Medical Store Organisation/Government Medical Store Depots and Central Governmen Health Scheme. Standard Operating Procedures have been developed to avoid any misappropriation in the suppl y of drugs.

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