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Pharma ACTD Dossiers


Pharma ACTD Dossiers



Pharma ACTD Dossiers is the healthcare industry’s No. 1 choice for regulatory affairs services in India and provide consultancy on  regulatory affairs in pharmaceutical and other related industries where regulations are continuously  evolving and more scientific expertise can create a difference. We are doing very well since last passed 4 years in the field of pharma regulatory documentation. We offer wide range of services including Regulatory Affairs Consultation Product Classification, Laboratory Testing, Medical and Lingual Translation, Manufacture Registration, Product Registration, Advertisements Approvals.
We are doing very well since last passed 4 years in the field of pharma regulatory documentation having a very highly skilled team of writers, resaerchers and testers. We care about your time and money. We provide work within client deadlines.
We have expanded our business to many countries and going on.
                  

        INDIAN DRUG REGULATORY SYSTEM

The Indian pharmaceutical industry is the world's second-largest by volume and is likely to lead the manufacturing sector of India. The number of purely Indian pharma companies is fairly low. Indian pharma industry is mainly operated as well as controlled by dominant foreign companies having subsidiaries in India due to availability of cheap labor in India at lowest cost. In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia [25]. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market.The government started to encourage the growth of drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.


Indian Pharmaceutical Market
Indian Pharmaceutical Market- $12 Bn- Growth – 12.14% per year
Export 4.2 Bn
Import 905 m
13th largest in value
3rd Largest in volume
100 US FDA approved manufacture sites
MNC ’s contribution to Pharma for domestic use- 20 %

According to our new report, “Booming Generics Drug Market in India”, the Indian generic drugs market has posted an impressive growth pattern over the last few years. Currently, the Indian pharmaceutical market is fully dominated by generic drugs and in the near future, this scenario is likely to remain the same. In FY 2010, the share of generic drugs in the overall pharmaceutical market was estimated to be around 79.2% and by FY 2013, the share is likely to escalate to around 80.5%
We have found that generic drugs developed by India are now distributed and sold in several parts of the globe that, in turn, has augmented the demand for Indian generic drugs. With the key drugs going off-patents in the coming future, which also include blockbusters, there is an immense opportunity for Indian generics manufacturers to strengthen their market share in countries, such as the US, Europe, and Japan.
Broadly Indian Pharmaceuticals sector is classified into Bulk drugs, Formulation and Contract Research and Manufacturing Services (CRAMS). The drug and pharmaceuticals industry in India meets around 70% of the country’s demand for bulk drugs, drug intermediates and formulations. There are about 500 corporate players with more than 20000 players in general and thus fragmented Indian pharmaceutical industry. The bulk drugs and pharmaceuticals manufacturers produce complete range of pharmaceutical formulation and about 350 bulk drugs.

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