Abstract
Indian Pharmaceutical Industry is the third largest in the world in terms of volume and this industry has a business of about USD 30 billion annually. Availability of quality medical products, especially drugs is important from the perspective of health of the consumers. The manufacture and sale of drugs in India is a licensed activity under Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The use of ineffective, poor quality, harmful medicines can result in therapeutic failure, exacerbation of disease, resistance to medicines and sometimes death. Proper and effective enforcement of the Act is mandatory for curbing the sale, distribution and consumption of spurious which is not of standard quality medicines in any country, there by safeguarding the public health. In this paper, we report a post market quality survey of 3925 drug samples over a period of 30 months. Drugs Control Laboratory, Vijayawada, India during the said period (Jan, 2015 to June, 2017) 3925 samples were analyzed. It was found that, in the year 2015, 2016 and 2017 (up to June) the percentage of NSQ drugs was 5.70, 1.92 and 2.27%, respectively. The effective enforcement of Drugs and Cosmetics Act, 1940 is necessary at the field level to ensure that, safe medicines are made available to general public by and large. Key words: Public health, spurious drug, not of standard quality drug, D & C Act 1940, Andhra Pradesh.
Highlights
The Indian Pharmaceutical Industry is presently the third largest in the world
Under section 22.1.b (i) and (ii) of the Drugs and Cosmetics Act, 1940 (D and C Act) of India, about 3925 drug samples falling into 23 therapeutic categories were lifted and sent by 59 Drugs Inspectors of Andhra Pradesh state received in Drugs Control Laboratory (DCL), Vijayawada, India
During the sampling period from January, 2015 to June, 2017 drugs and cosmetics samples in 3925 numbers were analyzed in DCL, Vijayawada belonging to 23 different therapeutic categories as part of enforcement of Drugs and Cosmetics Act in the state of Andhra Pradesh in post market survey (Table 1)
Summary
The Indian Pharmaceutical Industry is presently the third largest in the world (volume wise). The size of the industry is approximately Rs. 2,00,000 Crores (USD 30 billion), out of which more than half is exported to different countries across the globe. The Indian Pharmaceutical sector has shown an exponential growth over the last 10 years. The growth of the sector over a short period of time has thrown up challenges for, up scaling the regulatory structure in the country. Availability of quality medical products, especially drugs is important from the perspective of health of the consumers. NSQ drugs may lead to sub-therapeutic dosage, and give rise to anti-microbial resistance which is a major health concern
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