Lok Sabha Question No. 4481 (UNSTARRED), answered on 2016-08-12
Subject: Banned Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: JYOTIRADITYA MADHAVRAO SCINDIA, KAMAL NATH

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

## LOK SABHA UNSTARRED  QUESTION NO. 4481 TO BE ANSWERED ON 12 TH AUGUST, 2016

## BANNED DRUGS

## 4481. SHRI JYOTIRADITYA M. SCINDIA: SHRI KAMAL NATH:

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

- (a) whether the Government is aware that various global regulatory agencies especially in USA and UK have banned several drugs from India, if so, the details thereof;
- (b) whether the Gov ernment has identified flaws in the drug regulation regime, if so, the details thereof;
- (c)  whether  the  World  Health Organization  (WHO)  has  issued  number of  warnings  to  drugs manufacturers in India; and
- (d) if so, the details thereof and the steps Government proposes to take in this regard?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI FAGGAN SINGH KULASTE)

- (a): For export of drugs, Indian Pharmaceutical companies are required to comply with regulatory  provisi ons  of  the  importing  country.  Isolated  reports  of  the  drugs  not  meeting prescribed standards have appeared in the media and on the websites of the regulatory aut of foreign countries, etc. from time to time. Information of ban on firms for expo rt of drugs manufactured at their sites is generally not officially communicated to the CDSCO.
- (b): The gaps and weaknesses of regulatory regime in the country have been identified. Government has taken a series of measures to plug the gap s. Aproposal for strengthening of drug regulatory system in the country, both at the Central and State levels has been appr cost  of  Rs.1750  crore.  Out  of  this,  Rs.900  crore  is  for  strengthening  of  Central  re structures while Rs.850 crore has b een approved as the Central Government's contribution for upgrading and strengthening the States' Drug Regulatory System. The Government is committed to ensuring that the quality, safety and efficacy of drugs are not compromised. With this and  tocheck  the  marketing  and  manufacturing  of  spurious,  adulterated,  misbranded,  s -standard and expired drugs in the country, the Government has taken a series of measures. include  stringent  penalties  including  making  certain  offences  cognizable  and  non - bailable;

establishment of special designated Courts for trial of offences under the Drugs and Co Act  for  speedy  disposal  of  cases;  announcement  of  a  Whistle  Blower  Scheme  to  encoura vigilant public participation for detection of movement of spur ious drugs in the country; issuance of  guidelines  to  the  State  Drugs  Controllers  for  taking  action  on  samples  of  drugs  d spurious, adulterated, misbranded or 'not of standard quality'; instructions to the concerned staff to keep a vigil and draw sam ples of drugs for test and analysis for monitoring the quality drugs moving in the country; increase in the number of posts in Central Drugs Standard C Organization (CDSCO); re - equipping the drug testing laboratories with state of a equipment; large  scale  nation -wide  survey  to  determine  the  'not  of  standard  quality'  drugs; conducting workshops and training programmes for skill enhancement in areas such as Go Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Distribution Prac tices (GDP), Good Clinical Practice (GCP) and Goo  Storage and Distribution Practices (GSP) to regulators and industry in partnership with other Departments, industry and regulators countries  including  USA  and  European  Union.  Several  training  pro grammes  have  also  been conducted  for  laboratory  personnel  of  the  State  and  Central  laboratories  to  upgrade analytical capabilities and skill sets. Separately, CDSCO has commenced risk based inspections of manufacturing facilities.

- (c): No .

(d): Does not arise.