Lok Sabha Question No. 134 (UNSTARRED), answered on 2017-12-15
Subject: Patented Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: RAJESH RANJAN  (PAPPU  YADAV)

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

LOK SABHA UNSTARRED QUESTION NO. 134 TO BE ANSWERED ON   15 TH DECEMBER, 2017

## PATENTED DRUGS

## 134. SHRI RAJESH RANJAN:

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

- (a) whether only 5 percent drugs are patented in the country at present and if so, the action plan of the Government to increase the number of patented drugs at local level;
- (b) whether the patients have to face a lotof trouble due to delay in approving new drugs by the Government at global level in view of the fact that presently there are 30 lakh cancer patients in the country;
- (c) the number of drugs provided by the Government at affordable rates in the country along with the  criteria  to  select  such drugs  and  whether  the  Government  is con idering  to  include  more drugs in the list of affordable drugs; and
- (d) whether difficulties arises in controlling the prices of patented medicines due to its shortage in the country if so, the steps taken by the Government in this regard ?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a): As per data made available by Indian Patent Office, the number of patents granted by Indian Patent Office in pharmaceutical field from 2005 - 06 onwards, is as below:

| Year                          | Patents Granted   |
|-------------------------------|-------------------|
| 2005- 06                      | 457               |
| 2006- 07                      | 798               |
| 2007- 08                      | 905               |
| 2008- 09                      | 1207              |
| 2009- 10                      | 530               |
| 2010- 11                      | 596               |
| 2011- 12                      | 282               |
| 2012- 13                      | 344               |
| 2013- 14                      | 256               |
| 2014- 15                      | 389               |
| 2015- 16                      | 370               |
| 2016- 17                      | 551               |
| 2017- 18 (Upto 31/10/2017)398 |                   |
| Total                         | 7083              |

(b): As  and  when  the  applications  for  grant  of  permission  to  import/  manufacture marketing of any new drug including anticancer drugs are received by Central Drugs Stan ControlOrganisation (CDSCO), the applications are evaluated in consultation with the Sub Expert  Committees  (SECs)  and  permission  is  granted  in  accordance  with  the  Drugs  an Cosmetics  Rules,  1945  and  the  applicable  guidelines  based  on  the  recommendation  of Committee.  There  are  provisions  under  the  Drugs  and  Cosmetics  Rules,  1945,  under  whic permission  to  import/manufacture  for  marketing  of  new  drugs  can  be  granted  without  l clinical trial under certain conditions to make such drugs available early in t he country in public interest.

(c): The  National  Pharmaceutical  Pricing  Authority  (NPPA)  under  the  Department  of Pharmaceuticals has fixed the ceiling price of 849 essential medicines to make them affo Further,  affordable  Medicines  and  Reliable  Imp lants  for  Treatment  (AMRIT)  Deendayal Pharmacies are being opened by M/s HLL Lifecare Ltd., a PSU under the Ministry of Health Family Welfare, with an objective to make available drugs and implants at discounted pri the patients suffering from Ca ncer  nd Cardiovascular Diseases.

(d): In the Drug (Prices Control) Order 2013, only Indian patents based on the indige research and development are recognized for price control exemption.