Lok Sabha Question No. 2423 (UNSTARRED), answered on 2018-01-02
Subject: Tweaking of Drugs Formulations
Ministry: CHEMICALS AND FERTILIZERS
Asked by: K. MARAGATHAM

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

LOK SABHA UNSTARRED QUESTION No. 2423 TO BE ANSWERED ON THE 2 nd  January, 2018

## Tweaking of Drugs Formulations

## 2423. SHRIMATI K. MARAGATHAM:

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

- (a)  whether  the  pharmaceutical  companies  often  launch  new  drugs  after  tweaking  drug formulations by combining them with other medicines to circumvent price control and if so, the details thereof;
- (b)  whether  it  is  also  true  that  the  pricing  authority  has  found  most  of  these  medicines  to  be Fixed Dose Combinations (FDCs) and raised doubts on whether they had been approved by the Drug Controller General of India (DCGI) and if so, the details thereof;
- (c) whether the DGCI has said that the practice was illegal and not in conformity with the law and would have disastrous consequences; and
- (d) if so, the details thereof and the corrective steps being taken in this regard?

## 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): Pharmaceutical companies also launch their products as a 'new drug' as defined in the Drug (Prices Control) Order, 2013.
- (b): The Office of Drug Controller General of India (DCGI) has informed that the combination of two or more drugs for the first time in the country is considered as 'New Drugs' under the Drugs &  Cosmetics  Rules,  1945.  Application  for  approval  of  such  New  drugs,  when  received  by Central  Drugs  Standard  Control  Organization  (CDSCO)  are  examined  in  consultation  with Subject Expert Committees (SEC) and decisions are taken based on the recommendations of SEC and fulfillment of requirements as per the said Rules.

(c)  &  (d):  As  per  the  Action  Taken  Report  (ATR)  on  the  Parliamentary  Standing  Committee report, DCG (I) vide letter dated: 15.01.2013 requested all the State Drugs Controllers to ask the concerned manufacturers to prove the safety and efficacy of FDCs licensed to manufacture for sale in the country without due approval from office of DCG(I) before CDSCO within a period of 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country. To examine the applications received in response to the direction of the DCG(I), Ministry of Health and Family Welfare has constituted an Expert Committee under the chairmanship of Prof. C. K. Kokate. On the basis of the recommendations of the said Expert Committee and in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940  (23  of  1940),  the  Central  Government  prohibited  the  manufacture  for  sale,  sale  and distribution for human use of 344 drug fixed dose combination vide gazette notification no. S.O 705(E) to 1048(E) dated 10.03.2016. However, various stakeholders filed various writ petitions in different High Court across the country and the said notification was quashed by Hon'ble High Court of Delhi vide its order dated 01.12.2016. Further, the Union of India challenged the order of  Delhi  High  Court  before  the  Supreme  Court  by  way  of  SLP.  Recently  on  14.12.2017, Supreme Court bench has issued Order that these FDCs should be sent to Drugs Technical Advisory Board (DTAB) constituted under Section 5 of the Drugs and Cosmetics Act, so that it can examine each of these FDCs and send a report to the Central Government.