Lok Sabha Question No. 346 (STARRED), answered on 2021-03-19
Subject: Fixed Dose Combinations
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Ravneet Singh

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

## LOK SABHA STARRED QUESTION NO. 346 TO BE ANSWERED ON THE 19 TH MARCH , 2021 FIXED DOSE COMBINATI ONS

## *346. SHRI RAVNEET S INGH BITTU:

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

- (a) whether the Government is aware that several unscientific combinations have flooded the markets as Fixed Dose Combinations (FDCs) and if so, the thereof;
- (b) wheth er a lax regulatory framework has led to this situation in the coun so, the reaction of the Government thereto;
- (c) whether the National Pharmaceutical Pricing Authority (NPPA) has raise concerns on drug cocktails and has flagged the issu e to the Indian Council of Medical Research (ICMR) and if so, the details thereof;
- (d) the details of FDC drugs banned during the last three years;
- (e) whether the Government has taken any measures to fix the prices of ne which were FDC medicines or drug cocktails; and
- (f) if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE

## (DR. HA RSH VARDHAN)

- (a)to ( f )A Statement is laid on the Table of the House.

## STATEME NT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 346* FOR 1 9 TH MARCH , 2021

(a) to (d): The manufacture, sale and distribution of drugs in the country a under the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder thr system of licensing and inspection. Licenses for manufacture, sale and dist of drugs are granted by the State Licensing Authorities (SLAs) appointed by re State Governments. Under the said Rules, Fixed Does Combinations is a new D For the manufacture of any FDC falling under the definition of New Drug, permission is required  from  Central  Drugs  Standard  Control  Organsiation  (CDSCO)  bef obtaining manufacturing license for the New Drug from the concerned State Li Authority.

Under the afore - said Act, manufacture/sale/distribution of any banned drug punishable offence. State Licensing Authorities are empowered to take actio regard.

Some cases of grant of manufacturing license of new drugs including Fixe Combinations  (FDCs)  falling  under  the  purview  of  Rule  122E  of  the  Drug Cosmetics Rules, 1945 by some of the State Licensing Authorities (SLAs) with approval of the Drugs Controller General (India) [DCG (I)] came to the noti Government.

Apart from issuing repeated statutory directions under Section 33P of t he Drugs & Cosmetics  Act,  1940  to  the  State Governments not  to  issue  such  licenses  to  FDCs falling  under  definition  of  new  Drugs  without  approval  of  DCG(I), the  Central Government constituted an Expert Committee under the chairmanship of Prof Kokate t o examine the safety and efficacy of such FDCs.

Based on the recommendations of the Prof. C. K. Kokate Expert Committee Central Government prohibited 344 FDCs vide notification dated 10.03.2016. F the Central Government also prohibited 5 FDCs vide notification dated 08.06.2017.

However, with respect to prohibition of the said 344 FDCs, several writ were  filed  in  different  High  Courts  across  the  country  challenging  the  b FDCs. After that,  the  Hon'ble  High  Court of Delhi vide its order dated 01.12.201 quashed the said notification. The Union of India challenged the said order of Hon'ble Delhi High Court before the Hon'ble Supreme Court by way of filing Special Leave Petition  (SLP).  Further,  about  20  cases  agains t  5  FDCs  prohibited  on  08.06.2017 which  were  pending  before  various  High  Courts  across  the  country,  were transferred to Supreme Court. Hon'ble Supreme Court , vide  its  order  dated 15.12.2017 , directed  that  an  analysis  be  made  in  greater  depth  and  these cases  of (344+5) FDCs should go to the Drugs Technical Advisory Board (DTAB) and/or Sub-Committee formed by the DTAB for the purpose of having a relook into cases.

Accordingly, a Sub - Committee of DTAB was constituted which after providing hearing  to  all  the  petitioners/appellants,  submitted  its  report  to  DTAB accepted by DTAB.

Based  on  the  recommendations  of  DTAB, the  Central  Government , vide notifications  dated  07.09.2018 , prohibited  328  FDCs  for  manufacture,  sale  o distribution . The  Government  also  restricted  06  FDCs  for  manufacture,  sale distribution  with  certain  conditions vide  notifications  issued  on  the  same  dat However, various firms/stakeholders have filed writ petitions in various Hi across the c ountry including the Hon'ble Supreme Court against the said notifications dated 07.09.2018.

Earlier , in 2007, CDSCO had received complaints from consumer associati regarding  rationality  of  certain  Fixed  Dose  Combinations  (FDC)  marketed country. As follow up action, CDSCO prepared a list of 294 FDCs and communicat to State Drugs Controllers vide letter dated 14.08.2007. A writ petition was Hon'ble High Court of Madras and the Hon'ble Court granted stay order. However, DTAB in its meet ing held on 16.1.2008 constituted a sub -committee to examine these FDCs. The recommendation s of the subcommittee was referred to Hon'ble Supreme Court.  The  Hon'ble  Supreme Court in its  judgment ,dated 15.12.2017 ,accepted the recommendation s of DTAB and o rdered for disposal of these petitions. Accordin Central Government vide notifications S.O. 180(E) to S.O.259 (E) ,dated 11.01.2019 , prohibited 80 FDCs for manufacture, sale or distribution .

National  Pharmaceutical  Pricing  Authority  (NPPA) , under  the  M inistry  of Chemical & Fertilizers ,flagged the following to Indian Council of Medical Resea (ICMR), New Delhi. The detail is as below:

'' The  Authority  noted  that  the  retail  price  applications  of  new  drug consist  of  Fixed  Dose  Combinations  (FDCs) of  two  or  more  drugs.  The  Authority deliberated upon the matter in detail and expressed its concern that approva FDCs may compromise the rationale in the usage of the drugs and may lead t medication. The Authority also apprehended that fix ation of retail price of these FDCs may lead to a higher price being fixed than the sum of the price of their components resulting in profiteering by the companies. The Authority is of that guidelines in the usage of these FDCs needs to be looked into. Accordingly, the Authority  requested  that  matter  may  be  highlighted  to  Indian  Council  of research (ICMR), New Delhi."

(e) & (f): NPPA which is mandated with the task of dealing with pricing iss drugs fixes the retail price of only those new drugs which have been app Objection Certificate (NOC) issued by CDSCO. Further, NPPA has extended retail price to 1495 FDCs under DPCO 2013.

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