Medicines for Type 2 Diabetes and risk of use queried in Lok Sabha

(a) & (b) The International Diabetes Federation estimates that 61.3 million persons aged 20 years and above in India had diabetes in 2011 as against 51 million persons in 2009. Type 2 diabetes pre-dominantly affects adults aged 20 years and above. State/UT wise and year-wise data on number of persons affected by diabetes are not available. Government of India launched the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) in 2010 in 100 Districts of 21 States with a focus on awareness generation for behaviour and life-style changes, early diagnosis of persons with high levels of risk factors and their referral to higher facilities for appropriate management. It has also been envisaged to build capacity at various levels of health care system for prevention, diagnosis and treatment of NCDs including diabetes. 

(c) & (d) The drug ‘Rosiglitazone’, indicated for the management of Type 2 Diabetes mellitus, was reported to be associated with higher risk of cardiovascular events i.e. congestive heart failure and myocardial infarction (heart attack). The drug was prohibited for manufacture and sale in the country vide Gazette Notification G.S.R. 910 (E) dated 12th November, 2010 issued by the Ministry of Health & Family Welfare. 

(e) Quality of approved medicines, including medicines for treatment of type 2 diabetes, are regulated under the Drugs and Cosmetics Act, 1940 and rules made thereunder, through a system of inspection, licensing and random sampling and testing. In case any drug is likely to pose health risk(s) to human beings or that drug does not have the therapeutic value claimed or purported to be claimed or it contains ingredients for which there is no therapeutic justification, the Central Government may, by notification in the Official Gazette, regulate, restrict or prohibit the manufacture, sale or distribution of such a drug in public interest under Section 26 A of Drugs & Cosmetics Act 1940.

The above information was submitted by MoH&FW in reply of undermentioned Lok Sabha queries:-

GOVERNMENT OF INDIA

MINISTRY OF HEALTH AND FAMILY WELFARE

LOK SABHA

STARRED QUESTION NO 24

MEDICINES FOR TYPE 2 DIABETES

(a) Whether the Government has taken note of the rising number of cases of type 2 diabetes, particularly among the children and young adults in the country; 

(b) If so, the number of such cases reported during each of the last three years and the current year along with the remedial steps taken/proposed by the Government in this regard, State/UT-wise; 

(c) whether the attention of the Government has been drawn to certain reports which suggest that the medicines being used for treatment of type 2 diabetes carry the potential risk of heart attack and stroke; 

(d) If so, the details thereof along with the reaction of the Government thereto; and 

(e) the steps taken/proposed by the Government to ensure efficacy and quality of medicines for the treatment type 2 diabetes and ban those which are dangerous for health.?

ANSWER

Source: Lok Sabha Q&A

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