Tag: pharmaceutical products

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.

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Zydus Cadila’s arm acquires two ANDAs from Teva

Zydus Cadila’s arm acquires two ANDAs from Teva

20/06/2016 11:48

Pharma major, Zydus Cadila said that its arm Zydus Worldwide DMCC has acquired two ANDAs from Teva that are being divested by Teva as a pre-condition to its acquisition of Allergan’s generic business.

“The company has strengthened its US portfolio with the acquisition of two ANDAs from Teva that are being divested by Teva as a pre-condition to its acquisition of Allergan’s generic business,” Zydus Cadila said in a filing to the Bombay Stock Exchange.

The acquisition of these ANDAs is contingent on the closing of the Teva-Allergan Generics transaction and approval by the US Federal Trade Commission.

These ANDAs have been acquired by the company’s 100 per cent subsidiary, Zydus Worldwide DMCC and the transaction will be financed through the group’s internal accruals.

The acquired portfolio comprises an ANDA which is already commercialized and one pipeline ANDA which is a transdermal patch.

The estimated market size of the two ANDAs put together is nearly $200 Mio, it added.

This acquisition will help the company to expand its existing portfolio in the US and strengthen its pipeline of complex generic products.

Meanwhile, shares of the company were trading at Rs 315.70 apiece, up 0.75 per cent from the previous close at 11:48 hours on BSE.

India’s pharma exports likely to cross $20 bn by 2020: Study

India’s pharma exports likely to cross $20 bn by 2020: Study

16/06/2016 15:44

Export of pharmaceutical products from India is likely to cross USD 14. billion (bn) mark this year and may reach about USD 20 bn by 2020, thereby registering a compounded annual growth rate (CAGR) of about eight per cent, according to an ASSOCHAM-TechSci Research joint study.

“However, growth in pharmaceutical products’ exports from India may decline by almost half i.e. from the level of CAGR of about 15 per cent clocked during 2010-14 to about eight per cent during 2015-2020 on account of delay in regulatory approvals in top markets of the US, Russia, Africa and others,” highlighted the study titled ‘IPR in pharmaceuticals: Balancing, innovation and access,’ jointly conducted by ASSOCHAM and TechSci Research.

“Consolidation of pharmacy players is leading to an increase in pricing pressures for generic companies existing in the US market which is expected to result in decline in year-on-year growth of pharmaceutical exports from India over next five years,” highlighted the ASSOCHAM-TechSci Research study.

Besides, a steep decline in currency in emerging markets like Africa, Russia, Ukraine and Venezuela is expected to add woes to drug manufacturing companies that supply pharmaceutical drugs to that region and are unable to generate high revenues on account of selling their drugs at a low priced currency.

India is the largest supplier of medicine to the US. Pharmaceutical exports from India to the US rose from USD 3.4 bn in 2013 to $3.7 bn in 2014, mainly due to increasing demand for high quality generic drugs in the market.

However, growth rate for exports of pharmaceutical products from India to the US is declining, due to increasing US Food and Drug Administration (USFDA) scrutiny on the quality of pharma products coming from drug manufacturing plants located in India.

In order to boost growth rate of exports to the US, Indian companies will need to leverage their compliance to the USFDA regulations.

The exchange rate crisis in the country is affecting pharmaceuticals market in Russia. As such, stabilization of currency is of utmost importance in generating revenues through exports. In addition, many Indian companies are operating through the Pharmaceutical Benefits Program (PBP) and hospital tenders, for supplying vital and essential drugs, for which prices are then regulated by the Russian government.

Further, with a view to benefit and drive the growth of pharmaceutical research and innovation in India, the ASSOCHAM-TechSci Research study has recommended for data protection to be introduced as an Intellectual Property Right.

It has also suggested for digitisation of IPR for pharmaceuticals in India to strengthen online processing and maintenance of information database thereby making the process more systematic and convenient.