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Table 1 Milestones in initiatives begun in 2007 and 2013 to control proliferation of FDCs

From: Regulatory enforcement of the marketing of fixed-dose combinations in India: a case study of systemic antibiotics

 

First initiative (2007)

Second initiative (2013)

2007, November

States directed by MoHFW to cancel licences for 294 centrally unapproved FDCs (section  33P). Directions stayed by Madras High Court

 

2013, January

 

CDSCO sends “18 month policy decision” letters to state regulators

2014, January

 

Suresh Committee, and 10 Expert Committees set up

2014, September

 

Kokate Committee established, replacing Suresh Committee and 10 Expert Committees

2015, January

 

1st Kokate report published

2015, February

Summary of the evaluation of the 294 FDCs by the Gupta committee published

 

2015, April

 

2nd Kokate report published

2015, July

 

CDSCO issues first NOCs

2016, February

 

3rd Kokate report published

2016, March

 

Government bans (section 26A). Immediately stayed temporarily by Delhi High Court

2016, May

 

4th Kokate report

2016, December

 

Government bans ruled unlawful by Delhi High Court

2017, June

 

Government bans (section 26A)

2017, December

Supreme Court accepts Gupta committee report

Supreme Court set aside the judgment of the Delhi High Court, but remitted the matter to the DTAB

2018, February

 

DTAB sets up Kshirsagar committee

2018, July

 

Kshirsagar committee report published

2018, September

 

Government bans (section 26A)

2019, January

Government bans (section 26A)

 
  1. NOC  No Objection Certificate, DTAB  Drugs Technical Advisory Board. References to sections are to sections of the Drugs and Cosmetics Act 1940, as amended