This is not only because of the low-cost manufacturing, operations and research base but due to a combination of additional factors such as process improvements in manufacturing API (Active Pharmaceutical Ingredient), faster recruitment process for conducting clinical trials, availability of skilled manpower and developed regulatory skills. With, extremely competitive market, low costs and only process patents till recently, Indian companies have technologically advanced expertise in process innovation. The above factors have resulted in India producing low cost good quality products, which have spurred exports of Indian products to international markets, especially to the higher regulated markets like USA and Western Europe. Of the main export varieties, formulation and API sales are the major portion. INDIA’S EXPORT OPPORTUNITIES Figure 3: Trade Data of Indian Pharmaceutical Sector (IBEF, 2017) Indian pharmaceutical companies are taking advantage of Indian pharmaceutical sector’s export opportunities in regulated & semi-regulated markets.
As compared to the 1970s and 1980s where Indian Pharma Industry (IPI) was at the helm of the process capacities, the last few years have seen significant new IPRs being put into practice in. India. India inherited the patent laws from the British in 1856 almost 160 years ago. Although the British patent laws were westernized. Though there was significant progress in different types of industries in India, the domestic pharmaceutical industry somehow lagged behind in reaching higher standards during the British Rule.
Further clarifications have been made in obtaining compulsory licence to facilitate export of patented pharmaceutical products by Indian companies to countries that do not have adequate production capacities. TRIPS gave this instrument of compulsory licensing to governments so that they can allow domestic manufacturers to manufacture patented products within 3 years of their introduction. This would open an opportunity for manufacturers to export the medicines to other countries which are not in manufacturing of drugs. India has the opportunity to emerge as world leader in the field of export of drugs as India is rich in cost effective and intellectually competitive manpower and other resources. Pharmaceutical substance: The amendment currently describes Pharmaceutical substance as any new entity involving one or more inventive steps.
About $12 billion is spend on gifts and payment to physicians by pharmaceutical companies every year. This tends to impair the judgement of the HCP due to conflict of interest between patient safety and personal gain. India is 3rd largest pharmaceutical industry in terms of volume and world’s 13th largest by value representing nearly half the Rs.93000 crores market. It is even complicated by a highly privatised health system, an uneducated customer base, and the fact of "cross practice”, though it is illegal in most states in India. The sale of drugs was influenced by aggressive marketing strategies which included incentives to chemists.
CHAPTER 8 MAJOR CHALLENGES FACED BY THE INDIAN PHARMACEUTICAL INDUSTRY The Indian pharmaceutical industry was on a strong growth trajectory in the last decade. It has achieved several milestones. However, the industry needs to tackle various issues related to its operations and regulations. It faces several challenges in the form of pricing of pharmaceutical products and impact of some agreements. Impact of GATT-TRIPS agreement The General Agreement on Tariffs and Trade (GATT) and Trade Related aspects of Intellectual Property Rights (TRIPS) have an adverse impact on pricing of pharmaceutical products.
Europe and America gained popularity in best massage or therapy. In some India’s neighboring country of India like Srilanka. In Nepal and Bangladesh: Here Ayurveda has a better status as a patchy. Different countries have been classified into various category First category comes Nepal, Sri Lanka, and Bangladesh. Here system is practiced with recognition from government.
This is because the elimination and reduction of duties for the textile and apparel products will provide better access to new market such as US, Canada, Mexico and Peru. 4. Possible industry at disadvantage and badly effected The industry that might be badly affected is the pharmaceutical industry because of the strict intellectual property laws by the TPPA. The intellectual property (IP) rules will rise the patent and data protections for pharmaceutical companies, the price of medicines will increase incredibly high as well as the prevention of generic drugs into the market. Therefore it will be a critical situation to the pharmaceutical companies because they might be cannot afford the skyrocketing cost of medicine for serious illness such as AIDS and cancer.
Nonetheless, because of patent lapses and new effective medication dispatches, the positioning of top pharmaceutical organizations always confronts various varieties. The most sold medication in 2003 was Lipitor made by Pfizer, with a worldwide piece of the pie of 2.2%, or identically deals worth $10.3 billion. Amid this time, there were 64 blockbusters (items creating over $ 1 billion in deals). Also, the pharmaceutical area has been portrayed with a high M&A action – a certainty that further adds to the consistent variety in the rankings and the dynamism of the pharmaceutical business by and large. For instance, in 2003, preceding the merger occurred, Aventis involved fifth spot, as measured by level of incomes, and Sanofi came in thirteenth.
Cases Novartis The case of rejection of Novartis’ patent application for its cancer drug ‘Glivec’ is a classic example of the way India has incorporated appropriate safeguards in its patent laws to subdue the harmful effects of medical patents on accessibility of essential medicines. In this case, the safeguard is in the form on Section 3(d) of the Indian Patents Act, 1970. Novartis had filed an application with the Indian Patent Office in 1998 for inventing a new form ‘Imatinib Mesylate’ of its earlier molecule ‘Imatinib’. It failed to prove increased pharmacological efficacy. The Indian Patent Office rejected the application.
It has employed almost to 10 million Indians and hence, has contributing a lot to social transformation in the country. Furthermore, Indian business, across all other sectors, largely depends on the IT & ITeS service providers to make their business processes effective and profit making. The Indian manufacturing sector consists of the highest IT expenses followed by automotive industry, chemical and consumer product industry. IT is seen as change enabler and source of business values for organisations by 85% of the respondents, according to a study which was done by