Wednesday 1 June 2011

Drug Regulations in India


I express my sincere thanks and appreciation to all those, who in one way or the other inspired me in writing this Blog on Drug Regulations in India.
The availability of quality medicines at reasonable prices has been the subject matter of intense debate ever since independence of the country and the Central Government has been taking various steps to meet this objective.  From time to time, drug policies have been adopted to strike a balance between the often conflicting interests of industry and consumers in moving towards the objective of greater accessibility and affordability of drugs.  The present Government also attaches a high priority to this subject and has the declared objective of raising the public health expenditure and to make available life saving drugs at reasonable prices with special attention to the poorer sections of the society. The National Common Minimum Programme, as adopted by the earlier Government, United Progressive Alliance (UPA)-1 aimed as follows:

i)             UPA Government will raise public spending on health to be to at least 2-3% of GDP over the next 5 years with focus on primary health care.
ii)             A National Scheme for Health Insurance for poor families will be introduced.
iii)           The UPA will step up public investment in programmes to control all communicable diseases and also provide leadership to the national AIDS control effort.
iv)           The UPA Government will take all steps to ensure availability of life saving drugs at reasonable prices.
v)            Special attention will be paid to the poorer sections in the matter of health care.
vi)           The feasibility of reviving public sector units set up for the manufacture of critical bulk drugs will be re-examined so as to bring down and keep a check on prices of drugs.
vii)         The process of economic globalisation, which has resulted in further marginalisation of the poor, loss of livelihoods and increasing food, health and economic insecurity, has also further increased the disease burden. Most of these people have very little or no access to modern medicines. According to Planning Commission estimate 27.5% of Indian population is living below poverty line[1]. In India, about 35% people have access to Allopathic medicines. As per WHO study 650 M people (65%) in India lack access to medicines[2]. Indian households spend 50% of their total health expenditure on drugs & medicines[3]. Expenditure on medicines constitutes 79% of on-institutional healthcare expenditure[4]. After dowry, medical care is the second major cause of rural indebtedness in India[5].
In the era of liberalisation and globalisation how relevant is regulation? To answer this question it is necessary that we understand the pharmaceutical sector in India The most important characteristic of the pharmaceutical sector is that it is perhaps the only class of product in which the consumer i.e. the patient has virtually no choice that he can meaningfully exercise. In markets where competition works, the most bought and sold brand is the cheapest brand. The competitions by many producers bring down prices. Sellers and buyers are equally well informed about the product before making a purchase decision.
Food for Thought:
Following questions need debate:
a)            Do we expand price control on the non-scheduled segment also as recommended by the Health Ministry’s report on Macroeconomics and Health (2005)?
b)            How do we address the problem of knowledge asymmetry, which skews competition and makes the pharmaceutical market imperfect? What kind of pricing system will promote competition by addressing and minimizing barriers to competition?
Looking forward to your  valuable comments.

(L M Kaushal)



[1] The Expert Group  on Methodology for estimation of Poverty Chaired by Prof. Suresh D. Tendulkar in its report submitted to Planning commission claimed the figure of  poverty in India as 37.2% instead of 27.5%.
[2] WHO study
[3] Report of the National Commission on Macroeconomics and Health, New Delhi, Sept 2005.
[4] 6oth round of National Sample Survey(NSS)
[5] The Reserve bank of India (RBI) Rural Indebtedness survey of late eighties showed that amongst non-production loans healthcare was the first reason and amongst all loans it was the 2nd reason for indebtedness. The 52nd NSS Round on morbidity, utilizations and expenditure mention hospitalization as major cause for indebtedness.