Lok Sabha Question No. 3437 (UNSTARRED), answered on 2016-12-06
Subject: Indian Pharma Market
Ministry: CHEMICALS AND FERTILIZERS
Asked by: GAJANAN CHANDRAKANT KIRTIKAR, VIJAY KUMAR S.R., SUDHEER GUPTA, ASHOK SHANKARRAO CHAVAN, KUNWAR HARIBANSH SINGH, SUNIL BALIRAM GAIKWAD, T. RADHAKRISHNAN

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA UNSTARRED QUESTION No. 3437

## TO BE ANSWERED ON THE 6 th  December, 2016

## Indian Pharma Market

3437.   SHRI GAJANAN KIRTIKAR:

SHRI S.R. VIJAYAKUMAR:

SHRI SUDHEER GUPTA:

SHRI ASHOK SHANKARRAO CHAVAN:

KUNWAR HARIBANSH SINGH:

DR. SUNIL BALIRAM GAIKWAD:

SHRI T. RADHAKRISHNAN:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a)  the  present  overview  of  India's  Pharma  market  as  compared  to  the international pharma market;
- (b)  whether  the  Government  has  set  a  target  of  making  Indian  Pharma market a world leader by 2020;
- (c)  if  so,  the  details  thereof  along  with  the  assistance  provided  by  the Government  for  improving  manufacturing  standard  in  the  country  and genetic as well as innovator market in pharmaceutical sector;
- (d) whether the Government has reduced the time required for approval for new facilities to attract more investments in the country and if so, the details thereof; and
- (e)  the  steps  taken/being  taken  by  the  Government  to  check  counterfeit drugs available in various parts of the country?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a) : The Indian Pharmaceutical market is ranked 3 rd globally in volume and 14 th in terms of value, supplying around 10% of the total global production.
- (b): The policies of the Government play a vital catalytic role in spurring the growth of the  pharmaceutical  industry  in  the  country  and  strengthen  it  to become a global leader in the comity of nations in the global economy.
- (c): In order to promote the Indian pharma sector to make it a global leader by 2020, the government is running various schemes like Cluster Development Programme for Pharma Sector (CDP-PS) for providing financial assistance  for  common  facilities  in  pharma  parks,  for  providing  interest subsidy for improving Good Manufacturing Practices (GMP) compliance etc. The Government is also providing incentives for Research and Development.

The Government has also recently in order to provide level playing field to the  domestic  manufacturers  has  withdrawn  custom  duty  exemption  on certain categories of drugs/ medicines.

(d):  Central  Drugs  Standard  Control  Organization  (CDSCO)  has  recently introduced  online  portal  'SUGAM'  where  applicant  can  apply  online  for various permissions/Licences such as permission for Import & Registration of drugs  &  Medical  Devices  &  Diagnostics,  Test  License,  Cosmetics,  Ethics Committee  Registration  etc.  The  applicant  can  also  track  the  status  of submitted  application,  reply  to  the  raised  queries  and  can  also  upload essential documents for clearance of their applications.

(e): The term 'Counterfeit drugs' is not defined under Drugs and Cosmetics Act, 1940. The Govt. of India has been taken/taking following steps to check the menace of spurious drugs in the country:

1. The Drugs and Cosmetics Act, 1940 was amended under Drugs & Cosmetics  (Amendment)  Act  2008  to  provide  stringent  penalties  for manufacture of spurious and adulterated drugs. Certain offences have also  been  made  cognizable  and  non-bailable  by  setting  of  special Courts.
2. The States / UTs were requested to set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal. So far, 22 States have already set up designated special Courts.
3.  A  Whistle  Blower  Scheme  was  announced  by  the  Government  of India  to  encourage  vigilant  public  participation  in  the  detection  of movement of spurious drugs in the country. The scheme provides for suitably rewarding the informers for providing concrete information to the regulatory authorities in respect of movement of spurious drugs.
4. 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  were  forwarded  to  the State Drugs Controllers for uniform implementation.
5.  The  inspectorate  staffs  have  been  instructed  to  keep  a  vigil  and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country.
6. The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been increased from 111 in 2008 to 474 in 2016.
7. The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.

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