Lok Sabha Question No. 4089 (UNSTARRED), answered on 2016-12-09
Subject: Business of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: KUNWAR PUSHPENDRA SINGH CHANDEL

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

## LOK SABHA UNSTARRED QUESTION NO. 4089 TO BE ANSWERED ON 9 TH DECEMBER, 2016

## BUSINESS OF DRUGS

## 4089. SHRI KUNWAR PUSHPENDRA SINGH CHANDEL:

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

- (a) whether the Government has taken cognizance in regard to charging excessive prof t from the business of various drugs including life saving drugs;
- (b) if so, the effective steps aken by the Government to rationalise the said profits; and
- (c) the efforts being made by the Government to check the manufacturing and supply of spurious drugs?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYA PATEL)

- (a) & (b): The ceiling prices of essential medicines included in Schedule I of Drug (P Control) Order, 2013 (DPCO) are fixed after taking into account the average of Price to R (PTR)  of  all  brands  of  all  scheduled  formulations  having  a market  share  of  more  than  1%. Thereafter, retailer margin of 16% is added for the purpose of determining the ceiling case of non - scheduled formulations, the MRP cannot be increased by more than 10% of the MRP during  the  preceding  12  month  period. Whenever  companies  are  found  selling  medicines  at prices  higher  than  the  mandated  prices,  action  is  taken  against  them  under  the  provis DPCO 2013.
- (c): The Government is committed to ensuring that the quality, safety and efficacy of are not compromised. With this in view, the Government has taken a series of measures. Th include:
- I. stringent penalties including making certain offences cognizable and non - bailable;
- II. establishment  of  special  designated  Courts  for  trial  of  offences  under  the Drugs  and Cosmetics Act for speedy disposal of cases;
- III. announcement of a Whistle Blower Scheme to encourage vigilant public participation detection of movement of spurious drugs in the country;
- IV. issuance  of  guidelines  to  the  State  Drugs  Controllers for  taking  action  on  samples  of drugs declared spurious, adulterated, misbranded or 'not of standard quality';
- V. instructions to the concerned staff to keep a vigil and draw samples of drugs for analysis for monitoring the quality of drugs moving in the country;
- VI. increase  in  the  number  of  posts  in  the  Central  Drugs  Standards  Control  Organiza (CDSCO);
- VII. re - equipping of drug testing laboratories with state - of - art equipment;
- VIII. large scale nation -wide survey to determine the 'not of standard quality' drugs;
- IX. conducting workshops and training programmes for skill enhancement in areas such Good  Manufacturing  Practices (GMP),  Good Laboratory  Practices  (GLP), Good Distribution  Practices  (GDP),  Good  Clinical  Practices  (GCP)  and  Good  Storage  an Distribu tion  Practices  (GSP)  to  regulators  and  industry  in  partnership  with  o Departments,  industry  and  regulators  of  other  countries  including  USA  and  Europe Union.
- X. Conducting training programmes for laboratory personnel of State laboratories t o upgrade their analytical capabilities and skill sets.
- XI. risk based inspections of manufacturing facilities.

and

Centr