Active Pharmaceutical Ingredients
Indian Pharmaceutical Industry The pharmaceutical industry in India has seen an unlikely development. The Indian Industry has been able to make all essential drugs covering a wide range of therapeutic groups. The industry also has the potential to produce the right amount of bulk drugs for export worldwide. The patents in pharmaceuticals play an important role in bringing new products to market. Patent protection for pharmaceutical products is essential in contrast to other industries because the actual manufacturing process is easy to imitate, and can be replicated with just a small investment required for research and clinical trials. Local Anesthetics Indian Travel Law & Compliance Patents Act 1911 patent provided all known methods of manufacture of a medicament. Subsequently the Patents Act 1970 excludes patent protection for pharmaceutical products and allowed the patenting of a single process or method used in the actual manufacturing for a period of 7 years. This act provided benefit Indian manufacturer to patented drugs by another method and market in India. The scene changed again when India is a signatory to the WTO is required to comply with the provisions of the TRIPS Agreement to incorporate the product patent. Also, with this agreement, patents provide protection rights 20 years. For developing countries like India, a transition period of 10 years from 19952005 was provided to integrate the laws. In this view, the provision provided India "mailbox" to provide a means for inventors filing for pharmaceutical products during the transition period and will be reviewed at the end of the transition period . They were also granted exclusive marketing rights for a term of 5 years in the transition period. Therefore, the provision of mailbox allows applicants to apply for patents in India and therefore establish filing dates , while at the same time allows India differs from the granting of patents for pharmaceutical products. Yet another concern was with regard to the availability of medicines in poor countries. This issue was addressed by the introduction of compulsory licensing as a requirement under the Doha Declaration on the TRIPS Agreement . Compulsory licensing of pharmaceuticals authorized member countries to issue a compulsory license to export generic versions of patented medicines to countries with insufficient or no capacity in the pharmaceutical sector. In developing countries like India , compulsory licensing is probably the most effective protection against possible abuse of monopoly patents. Current Scenario
Due to legal and regulatory changes in the pharmaceutical industry in India , pharmaceutical companies have adapted well and have evolved as companies globally competitive . Indian companies have continued to invest significant resources in the development of generic drugs by establishing and leading generics business worldwide. Today the world 's leading pharmaceutical companies are facing difficulties as a significant number of patents for brand name drugs are expiring in the next few years . Generic drugs are 40 to 75 percent cheaper costs compared to patented drugs and provide a higher level than the branded drugs benefit. Once the patent expires , the individual characteristics and market position of each product affect its market share . Consequently pharmaceutical companies in India have the opportunity to gain a greater share of the growing market for generics. Lidocaine Hydrochloride Statistics of India IP Scenario of Indian pharmaceutical industry has changed significantly since the January 1, 2005 . Innovation capacity of the domestic pharmaceutical industry has witnessed an increase in both , research and patents. The number of patent applications filed in the Patent Office of India has increased steadily with an average annual growth of 9 % per annum from 2005 to 2010 . Throughout the period there have been a total of 16,459 applications for Drugs. The major players in the Indian pharmaceutical market comprise both India -based and MNCs. Top 10 Assignees who have been granted the maximum number of product patent by the Patent Office of India during the period 2005-2010 includes Aventis Pharmaceuticals ( 190 patents) , followed by Roche ( 146 patents) and Novartis (136 patents). Leading pharmaceutical companies in India are competing not only in domestic market but also in the global market for both generics and original products. Five pharmaceutical companies in India , has been awarded the most patents are product 2005-2010 Glaxo, CSIR , Dr. Reddy, Cipla and Cadila . These companies manufacture a wide range of generic ( brand and non-brand ) , intermediates and active pharmaceutical ingredients ( API). Conclusion The change in the pharmaceutical patent system became the precursor of the variation in the dynamics of the industry. The changing dynamics of the industry both nationally and internationally has forced pharmaceutical players to reevaluate their conventional business strategies . India, with its key competitive advantages is still one of the most preferred destinations for outsourcing and is now playing a vital role in manufacturing as well as drug development chain of several innovative companies. Mahendra Chemicals is an US FDA approved ISO 9001:2008 certified Lidocaine Drug and pharmaceutical manufacturer.