Tag: Drugs and Cosmetics

Ajanta Pharma bags approval for Entacapone Tablets

04/09/2017 11:03

Leading pharma major, Ajanta Pharma Limited has said that it has received final approval for Entacapone Tablets from US FDA. It is a bioequivalent generic version of Comtan®1 Tablets. Company will be launching the product shortly in 200mg strength tablets.

“Entacapone Tablets is part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 35 Abbreviated New Drug Application (ANDA) of which it has final approvals for 20 ANDAs; tentative approvals for 2 ANDA; and 13 ANDAs are under review with US FDA,” the company said in a filing to the Bombay Stock Exchange.

Ajanta Pharma Limited is a specialty pharmaceutical formulation company with global headquarters in Mumbai, India. Over 6,500 employees are engaged in developing, manufacturing and marketing of quality finished dosages across 30+ countries.

Meanwhile, shares of the company were trading at Rs 1202.10 apiece, up 0.10 per cent from the previous close at 11:08 hours on BSE.

Govt to withdraw Drugs and Cosmetics (Amendment) Bill, 2013

23/06/2016 09:20

The government of India has decided to withdraw the Drugs and Cosmetics (Amendment) Bill, 2013, which had been introduced in the Rajya Sabha on August 29, 2013.

The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill.

India is one of the largest manufacturers of pharmaceutical products in the world. The annual production of such products is in excess of Rs 2 lakh crore. Out of this, over 55 per cent is exported to over 200 countries of the world including the developed countries. As such, the pharmaceutical sector in India plays a vital role in managing the public health in large number countries at a substantially lower cost.

The regulatory framework for ensuring the quality, safety and efficacy of medical products including the medicines, medical devices, in-vitro medical devices, stem cells, regenerative medicines, clinical trial, etc. is provided for in the Drugs and Cosmetics Act, 1940.

The Cabinet has, keeping in view the role of the sector in managing public health, decided that it will not be appropriate to carry out further amendments in the present Act especially as newer areas of biological, stem cells and regenerative medicines, medical devices and clinical trial, etc. cannot be effectively regulated under the existing law.

In order to leverage the comparative cost advantage, the demographic dividend and the advantage in information technology, the Indian medical products sector is poised for exponential growth in the near future and it would besides meeting the domestic demand, has the potential to become an international hub for manufacturing these products and attracting investment in the sector.

Keeping in view the objective of make in India, it has been decided to comprehensively review the existing law with two fold objectives viz. to facilitate the ease of doing business and substantially enhancing the quality and efficacy of our products.