Introduction: Manufacturing Pharmaceutical Drugs in India
Drugs play a major role in healthcare delivery in the country. Continuous supply of drugs is necessary to ensure delivery of affordable healthcare to the citizens. Any disruption in the supply of drugs can have a significant adverse impact on drug security of the country.
A recent scheme announced for Production Linked Incentive (PLI) scheme for bulk drugs is aimed at cutting India’s dependence on imports of active pharmaceutical ingredients from China. The Centre, on 2022, March 29, announced that of the 53 drug raw materials for which India was dependent on imports, 35 are now being manufactured in India. This statement has been given by the Union health and chemical and fertilisers minister, Mansukh Mandaviya. Over 65% of India’s API imports come from China. But under this scheme, the government is providing the viability gap funding to reduce dependence on imports.
Raw Materials required for Production
Among the raw materials used by the pharmaceutical industry, hydrochloric acid and caustic soda are quite popular. Both of these chemicals are used for various syntheses required to manufacture many drugs. Hydrochloric acid and caustic soda for pharmaceutical applications are used as pH adjusters, catalysts in chemical reactions and as reducing agents. These material’s substances are also used to manufacture, for example, ascorbic acid, para-aminobenzoic acid, salicylic acid or polopiryna. PCC Group manufactures raw materials for pharmaceutical products in accordance with quality requirements set out in the European Pharmacopoeia. The offer of raw materials for the pharma industry also includes polyethylene glycols that are used as excipients. “Macrogols”, according to the European Pharmacopoeia, are compounds from the polyethylene glycols group. They are used as ingredients in the production of medicines, ointments, emulsions, dermocosmetic and other pharmaceutical products.
Another group of materials used in the pharmaceutical industry and which meet the requirements of the European Pharmacopoeia are raw materials for API synthesis (Active Pharmaceutical Ingredients). They include substances such as monochlorobenzene (MCB), orthodichlorobenzene (ODCB), phosphorus trichloride and phosphorus oxychloride.
Monochlorobenzene and orthodichlorobenzene are used in the pharmaceutical industry, for example, in the synthesis of drugs for liver diseases, thyroid and epilepsy. They are used in the production of paracetamol and vitamin B6. In the production processes, chlorobenzene and dichlorobenzene are used also as high-boiling industrial solvents.
Phosphorus trichloride and phosphorus oxychloride are used in the pharmaceutical industry as phosphorus-containing reagents for phosphorylation reactions, halogenating reagents in the substitution of hydroxyl groups, as well as activators in coupling reactions. These substances are involved in the synthesis of catalysts and cyclic compounds. They are mainly used for the production of drugs that are derivatives of isoquinoline. Phosphorus trichloride and phosphorus oxychloride have a high purity and high chemical reactivity that make them popular among pharmaceutical manufacturers.
PCC Group produces goods in compliance with the highest standards, including GMP EFfCI, ISO9001, ISO14000, and OHSAS, as a producer of pharmaceutical raw materials. Major pharmaceutical firms in Poland and around the world appreciate PCC Group’s high quality and purity of its pharmaceutical raw materials, which are sold to them. Due to their manufacture of cosmetic-grade raw materials, they also provide goods that are common to the pharmaceutical and cosmetic industries. Interdisciplinarity enables our customers to buy all active ingredients, raw materials, excipients, and additives from the world’s largest chemical company at one location.
Product Manufacturing States
Telangana and Andhra Pradesh, the central south states, have the most pharma CMO manufacturing of all Indian States. With Telangana, India, accounting for 35–40% of the nation’s pharmaceutical production, Telangana is well known as a centre for the pharmaceutical sector, and Hyderabad Pharma City, which is now under construction, will boost Telangana’s standing in this regard.
Domestic demand for medicines should also increase as the country develops and incomes increase, making healthcare more affordable to a larger proportion of the population. India currently imports nearly 80% of its APIs from China. This overreliance on China could make the pharma industry vulnerable. Recently, manufacturers have experienced a sharp spike in the prices of these raw materials due to rising labour costs and the Chinese government shutdown of numerous API manufacturing plants due to environmental concerns. If current trends persist, API sourcing from China will eventually lead to a reduction of Indian drug profitability. Consequently, India plans to promote domestic API production under the Make in India initiative to counter this overreliance on China. The Make in India initiative was launched in September 2014 as part of a wider set of nation-building initiatives with the goal to transform India into a global design and manufacturing hub.
Ahmedabad (in Gujarat state), Bangalore (Karnataka), Hyderabad (Telangana), and Mumbai (Maharashtra) are where the major pharmaceutical manufacturing hubs are located in India. These central and southern Indian states are the traditional powerhouses for pharma manufacturing in the country.
Infrastructure required; Promotion of Bulk Drug Parks
The Production Linked Incentive (PLI) scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) has been notified to boost domestic manufacturing of bulk drugs and reduce import dependence.
The Scheme for Promotion of Bulk Drug Parks has been notified to develop common infrastructure facilities (CIF) for bulk drug production units to reduce manufacturing costs. This will also help in reducing the impact on the environment through innovative waste management systems installed in the parks.
Under the scheme, financial assistance will be provided for the creation of CIFs in three bulk drug parks selected under the scheme. The assistance will be 90% of the project cost in northeastern states and hilly states while it will be 70% in other states. A bulk drug park project proposed by a state and selected under the scheme will be implemented by a State Implementation Agency (SIA) and will receive a maximum assistance of INR 1000 cr.
The scheme will be valid for a period of 5 years from FY 2020-21 to FY 2024-25 and has a total outlay of INR 3000 Cr.
The Indian pharmaceutical business ranks third globally in terms of volume and is valued at USD 40 billion. 3.5% of all medications and medicines exported globally come from this nation. India sells medicines to more than 200 nations and territories, including those with strict regulations like the United States, the United Kingdom, the European Union, Canada, etc. India offers a fully developed ecosystem for the development and production of pharmaceuticals, with businesses possessing cutting-edge facilities and highly qualified/technical labour. Additionally, the nation is home to a number of renowned pharmaceutical educational and research institutions as well as a strong support system for related companies.
Ananya Khar is a Research Intern at Tatvita. Presently she is pursuing his bachelors in the Liberal Arts department at the Savitribai Phule Pune University.