Author: Aimon Singh

Abstract

The unprecedented Covid -19 pandemic has resulted in human suffrage and a slump in the economy. The pharmaceutical sector was one such, where the whole world was dependent. India has continuously embarked on supplying pharmaceutical products at minimum rates. In a developing nation with over $42 billion, stakes are constructed by Indian pharmaceutical companies. The estimated ambition of the sector is to surge its valuation to $120 billion by 2030. This won’t be possible without reducing import dependence leading to cost cuts and self-dependence. The other obstruction is the IPR rights (i.e., Intellectual property rights) and the conundrum of medicinal companies. IP rights are those rights that stand for intellectual property, as said. Suppose a specific person is the creator of any drug. In that case, he shall be given the ‘Patent’ for it under the Patent Act,1970 certainly means no other companies can manufacture the same product unless they bought the rights from the person. Majorly MNCs (Multinational companies) seek these rights and profess the business globally. To gain the reputation of ‘India pharmacy as global market leader’. These twofold difficulties shall be resolved. The drug-related manufacturing is often regulated by TRIPS agreements globally. The change to the 1995 TRIPS agreement has shrunk affordable supply chain management in the pharmaceutical sector. The background is also the challenges faced by these companies and the Indian government to provide opportunities and ensure access to the drug (life-saving medicine).

Introduction: Pharmaceutical sector and Indian Laws

The drug and the medicinal sector have phases to be passed and established itself in the market. Starting with the science (or creation of medicine) to Patent processing (under the Patent Act)¹, and after that, patent granting and global manufacturing business. India has embarked as a leader in the sector by exposing medicine and covid doses to African countries. India has exported roughly 210 million quantities² to around 90 countries. The export of medicine on one side and the import of material for those manufacturing, on the contrary, is one such stoppage for the Indian pharmacy sector growth. Instead, India has a good reputation and is already the third largest manufacturer in the world, with China on top.

India is known as a world exporter for manufacturing medicine. Companies like Cipla, Ranbaxy, Aurobindo are ardent in the medicinal manufacturing sectors. The world leader in manufacturing of generic medicine has been escalated by the use of the regulatory sandbox of Medical sciences, economic perspective and patent laws. The trivia has bulwarked the interest of pharma sectors in India. The Indian Patent Act 1970³ was an important phase, where it transformed the generic medicine manufacturing for India. Prior to this the colonial rule stunted the development and forced to produce and export the medicine at an unaffordable rate. The 1911 patent Act only allowed licensing for 16, years and ceased the manufacturing of pharmaceutical products that were developed abroad. The 1992 LPG (Liberalisation, Privatisation and Globalisation,) of the economy finally ensured the Pharma companies to compete in world market and the 2005 Patent Act was final nail in the old Slave making pharma laws by the colonial government.

Indian Pharma Dominance and the ardent manufacturing hub 

The role of Indian companies in treating diseases like HIV-AIDS and a few others at an affordable price has also paved the way for a better future in the pharma sector. Companies like Cipla have ensured their top spot worldwide in the industry and are involved in much such research for life-saving medicines. The Patent (Amendment) Act 2005 has also provided a safeguard mechanism for generic drug production and companies. The evergreening of patents under section 3(d)⁴ of the Patent Act, 2005 has also boosted positive imperatives in the scientist’s mind. But, the Novartis incident (where MNC) bought the rights has also shown the power of corporates can overshadow the scientific creation in the pharma sector.

The pavement for a better future for the Indian pharmacy sector is to reduce its dependence on material costs for creating a new generic drug. India imports only one percent material from China. Still, the manufacturing cost for Indian pharmacy sectors and companies is a long time and a significant problem that is an obstacle in the way of becoming the leading generator and manufacturer of life-saving drugs. This dependence on the material cost of the import process is heavily costly and disrupts the Indian farmer supply chai⁵n.

The case study of Indian generic drug matters has a few significant achievements outlined for the Pharma sector. In the developing world, the early 1980 witnessed the spread of HIV and AIDS patients treated with antiretroviral (ARV) that can reduce the spread of the virus in the body. This invention results in the decline of death because of HIV AIDS. This success story of Indian pharmaceutical company Cipla finds the role of an Indian generic drug manufacturing company in providing affordable treatment for antiretroviral diseases. Instead, this Cipla could not get a license for the same because the Indian Patent Act was not in conformity with the TRIPS agreement until 2005⁶. The 2005 Indian Patent Act provides affordable medicinal treatment and safeguards for granting the patent. The provision for compulsory licensing was also included in the Act, which made it possible to manufacture the drug for the public interest and better good. It is still a legal battle between the generic producer and the compulsory license in the process⁷, which does not conform with Intellectual property rights.

Doctrine of Compulsory Licensing and Lifesaving Medicine (LSG)

The need to promote and develop research in the medicinal sector ought to be paramount as the cure or measures are the only way to provide necessary safeguards to society at large. But the Intellectual property which settles the monetary need of the inventor is in contravention of societal welfare. To address this situation the TRIPS agreement has included the concept of the “Doctrine of compulsory licensing“⁸. The Indian government has included this Doctrine in the 2005 patent Act. This is helpful as it allows the manufacturer (generic) to produce the medicine without the prior authorization of the patent holder.

This is done to ensure the societal need and welfare of society by combating the disease. As well, as to facilitate the research process. So, it has twofold development of promoting the research and producing the drugs at a certain cost. Though it addresses the welfare measure simultaneously, in the WTO’s Doha conference in 2001, it was stated that predominantly the medicine produced by taking compulsory licensing shall only be allowed to supply in the same domestic market. Article 31(f)⁹ of the TRIPS agreement argues the same, and this has been a matter of discussion for so long, as it was argued that the countries (underdeveloped) who are not in manufacturing shall be facing the problem, so the whole purpose of welfare will be refuted. But in paragraph 6 of the DOHA conference (2001) the requirements were waived off and “Life-saving medicines” (LSM) were allowed to be imported from developed countries. This concludes that by 2033¹⁰, the developed countries can import medicine from India but not export under the compulsory licensing scheme.

Conclusion – A way forward to reconcile the development of Indian Pharma sectors.

The recent development of a better and strengthened regulation process has ensured that the Indian pharmaceutical sector can be the world’s leading manufacturer. If it can survive the disparity between the TRIPS agreement and domestic patent processing. Indian Pharma companies are now also time up with MNCs off the contract to ensure global reach, safeguard better mechanism processes, and provide affordable life-saving medicines. The procedural and regulation part has been an evaporative aspect for the inventors and for the companies also. There could possible be single window system to leverage the Patent processing and documentation so that the focus of the inventors can only be on the invention. The other aspect ‘Invention’ has also been a strength for Indian medicinal science and drug manufacturing companies. The two-fold difficulty of providing economic justice to the inventor of the medicine by exclusive patent processing and addressing the need of society by providing Lifesaving medicine at cheaper cost. Both these challenges can be facilitated by adopting uniform mechanisms in the world. TRIPS agreement and DOHA Wto conference triggered the need of working of all the stakeholders: -Medical science, manufacturing industry and Law (patent) altogether to achieve manufacturing apex spot in the world.

The framework of the TRIPS agreement has also provided India’s national policy, which needs to be reformulated to prioritise the Right to health under Article 21 of the Indian constitution across the developing world. The constitutional validity of Social welfare by providing access to health safety under Fundamental right and Directive principle of state policy is Ought to be paramount.