Lok Sabha Question No. 518 (UNSTARRED), answered on 2018-02-06
Subject: WHO Report on Medical Products
Ministry: CHEMICALS AND FERTILIZERS
Asked by: BALASUBRAMANIAM SENGUTTUVAN

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

## LOK SABHA

UNSTARRED QUESTION No. 518

TO BE ANSWERED ON THE 6 th  February, 2018

## WHO Report on Medical Products

## 518. SHRI B. SENGUTTUVAN:

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

(a) whether the report of WHO Global Surveillance and Monitoring System for substandard and falsified medical products (GSMS) 2013-17 has found that just about 2% of the medical products manufactured  in  South-East  Asia,  including  India,  were  either  spurious  or  substandard  as against 21% in the Americas and as against the global figure of 10.5%;

(b) whether the report has also indicated that globally there was clear evidence that about 38 to 90% of the most important antimalarial medicine, artemisinin, available in the market are either substandard or falsified;

(c)  whether  the  Government  has  taken  steps  to  ensure  that  the  medicines  dispensed  by  the online pharmacies in India are up to the standard and genuine and if so, the details thereof; and (d) whether the Government would issue instructions to the pharmaceutical and pharmacological sectors to use bar codes in their products so as to eliminate circulation of the spurious imitation products and if so, the details thereof ?

## 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) & (b): Director-General, WHO Geneva has launched two documents concerning substandard and falsified medical products, at the Graduate Institute, Geneva:

(i) a study on the public health and socioeconomic impact of substandard and falsified medical products ; and

(ii)  WHO  global  surveillance  and  monitoring  system  for  substandard  and  falsified  medical products

They include estimations on the observed failure rates of sampled medicines in quality surveys carried  out  during  2007-2016,  involving  over  48,000  samples  from  88  Member  States.  The aggregate observed failure rates in low and middle income countries are estimated at 10.5%. As per the Report of WHO Global Surveillance and Monitoring System for substandard and falsified medical products (GSMS) 2013-17, 'there is clear evidence that resistance to the most important antimalarial  medicine,  artemisinin,  first  appeared  in  a  part  of  the  world  where  at  one  point between 38 and 90% of the artemisinin medicines on the market were substandard or falsified.'

(c):  Manufacturing,  sale  and  distribution  of  Drugs  in  the  country  are  regulated  under  the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945 made thereunder through a system of licensing and inspection. License for manufacturing, sale and distribution of Drugs are granted by  State  Licensing  Authorities  appointed  by  respective  State  Governments.  Licensees  are required to comply with all the conditions of such licenses. The State Licensing Authorities are empowered to take action in case of any violation of above requirements.

(d): Ministry of Health & Family Welfare has issued a draft notification vide GSR 449(E) dated 03-06- 2015 to amend the Drugs and Cosmetics Rules 1945 to make barcoding mandatory for drugs. However, a large number of comments were received raising difficulties to be faced by the industry, if the barcoding is made mandatory and the draft notification could not be finalized.