Lok Sabha Question No. 1643 (UNSTARRED), answered on 2019-07-02
Subject: Generic Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Kalyan Banerjee

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

LOK SABHA UNSTARRED QUESTION NO. 1643 TO BE ANSWERED ON 2 nd  July, 2019

## Generic Drugs

## 1643. SHRI KALYAN BANERJEE:

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

- (a) whether the Government has introduced generic drugs in the country;
- (b) if  so,  whether  the  prices  of  generic  drugs  are  cheaper  than  other  drugs available in the open market with the same composition;
- (c) the reasons behind the price variation of the same products;
- (d) whether the Government proposes to fix 'one product-one price' all over the country; and
- (e) if so, the details thereof and if not, the reasons therefor?

## ANSWER

## MINISTER IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI D. V. SADANANDA GOWDA)

(a): Drugs imported, manufactured and sold in the country are regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made thereunder. There is  no  definition  of  'Generic  drugs'  prescribed  in  the  said  Act  &  Rules  made thereunder.  However,  generic  medicines  are  generally  those  which  contain  same amount of same active ingredient(s) in same dosage form, and are intended to be administered by the same route of administration as that of corresponding branded medicines.

The medicines, whether  branded or generic,  imported or manufactured for sale,  distribution  in  the  country,  are  required  to  comply  to  the  same  standards  as specified in the Second Schedule to the Drugs and Cosmetics Act, 1940.

Central Drugs Standard Control Organization (CDSCO) grants permission to Manufacturer/import of new drugs under the provisions of Drugs and Cosmetics Act 1940 and Rules made thereunder in proper name. Details of number of permissions granted during the last three years are as below-

| Year   |   Number of Permissions Granted |
|--------|---------------------------------|
| 2016   |                             194 |
| 2017   |                             212 |
| 2018   |                             239 |
| Total  |                             645 |

(b) & (c): Both  generic  drugs  without  any  brand  name  and  branded  drugs  are treated alike for fixation of ceiling price under the provisions of Drugs (Prices Control) Order  (DPCO).  As  per  provisions  of  DPCO,  all  manufacturers  of  Scheduled medicines  (branded  or  generic)  have  to  sell  their  products  within  the  ceiling  price fixed by the Government. As regards non-scheduled formulations, the manufacturers are not allowed to increase the price by more than 10 % per annum. The prices are both fixed as well as monitored in case of scheduled medicines and monitored only in case of non-scheduled medicines by the National Pharmaceutical Pricing Authority (NPPA). In case a violation of an order issued under DPCO is detected, action for overcharging is taken as per provisions of DPCO.

- (d): No such proposal is under the consideration of the Government.
- (e): In view of (d) above, the occasion does not arise.

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