API Production. Cephalexin, Ampicillin Trihydrate, Ibuprofen and Paracetamol

API Production. Cephalexin, Ampicillin Trihydrate, Ibuprofen and Paracetamol. Production of Active Pharma Ingredients (API).

Active pharmaceutical ingredient (API), is the term used to refer to the biologically active component of a drug product (e.g. tablet, capsule). Drug products are usually composed of several components. The aforementioned API is the primary ingredient. Other ingredients are commonly known as "excipients" and these substances are always required to be biologically safe, often making up a variable fraction of the drug product. The procedure for optimizing and compositing this mixture of components used in the drug is known as "formulation."

An active ingredient is the ingredient in a pharmaceutical drug or pesticide that is biologically active. The similar terms active pharmaceutical ingredient and bulk active are also used in medicine, and the term active substance may be used for natural products. Some medication products may contain more than one active ingredient. The traditional word for the active pharmaceutical agent is pharmacon or pharmakon which originally denoted a magical substance or drug.

Paracetamol is used for the relief of mild to moderate pain. The use of the intravenous form for short-term pain in people in the emergency department is supported by limited evidence. In adults it appears to be useful for migraines, tension headaches, perineal pain after childbirth, and kidney stone pain.

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Ibuprofen is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches, or arthritis. It is also used to reduce fever and to relieve minor aches and pain due to the common cold or flu. Ibuprofen is a no steroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Market Outlook

India's PLI scheme intends to boost domestic production of bulk drugs including KSM, drug intermediaries, and APIs for antibiotics, steroids, anti-tuberculosis (TB), and diabetic medication amongst others, identified as critical for manufacturing in India. India is dependent on the import of these basic raw materials that are used to produce finished dosage formulations.

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The increasing occurrences of chronic diseases, growth in abbreviated new drug applications (ANDA), rising acceptance and uptake of biopharmaceuticals, and the growing importance of generics across the globe is expected to enhance the Active Pharmaceutical Ingredients Market growth. However, the stringent regulatory policies and adverse drug price control policies across numerous countries are likely to curb the growth of the market.

Specialty Medicines A Trend In the Active Pharmaceutical Ingredients Market

A higher generic adoption rate in developed countries that ranges from 27% to 32% is driving global medicine spending and aiding greater access to improved, lifesaving healthcare services. The adoption of branded generic drugs is predicted to be higher in emerging economies such as China and India and generic drugs accounted for nearly 80% of the total drugs sold by value in these fast-growing nations in 2016.

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Rising use of specialty medicines is anticipated to grow the pharmaceutical spending worldwide with quicker growth in richer, developed nations as compared to their emerging counterparts. This is primarily because the former have adequate manufacturing units, a higher spending power, and greater emphasis on transparent pricing by assessing measuring effects on the population.

The global market for biological is currently exhibiting strong growth catalyzed by their high potency and ability to treat diseases beyond the scope of small molecule drugs. This is creating a strong demand for APIs for branded biological drugs and their biosimilars versions.

Role of Government towards API

The coronavirus outbreak disrupting supply of active pharmaceutical ingredients (APIs) and medical devices from China to India, the government has come out with four schemes worth Rs 13,760 crore to encourage manufacturing of bulk drugs and medical devices in the country and their exports.

On March 21, the Union Cabinet under the chairmanship of Prime Minister Narendra Modi had approved an expenditure of Rs. 9,940 crore and Rs. 3,820 crore for APIs and medical devices, respectively.

The Cabinet also approved a scheme on promotion of bulk drug parks for financing common infrastructure facilities in three bulk drug parks with financial implication of Rs. 3,000 crore for next five years. The government will give grants-in-aid to states with a maximum limit of Rs. 1,000 crore per bulk Drug Park. Parks will have common facilities such as solvent recovery plant, distillation plant, power and steam units, common effluent treatment plant etc.

The government further approved production linked incentive (PLI) scheme for promotion of domestic manufacturing of critical KSMs/drug intermediates and APIs in the country with financial implications of Rs. 6,940 crore for next eight years.

Financial incentive will be given to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years.

Out of 53 identified bulk drugs, 26 are fermentation based bulk drugs and 27 are chemical synthesis based bulk drugs.

Rate of incentive will be 20 per cent (of incremental sales value) for fermentation based bulk drugs and 10 per cent for chemical synthesis based bulk drugs.

The PLI scheme will lead to expected incremental sales of Rs. 46,400 crore and significant additional employment generation over eight years.

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The drug industry has welcomed the incentives offered by the government to promote API units in India.

Besides APIs, the Cabinet also approved the scheme for promotion of medical device parks in the country in partnership with the states. A maximum grant-in-aid of Rs. 100 crore per park will be provided to the states. It will have financial implications of Rs. 400 crore.

The PLI scheme for promoting domestic manufacturing of medical devices will have financial implications of Rs. 3,420 crore for next five years.

Medical device is a growing sector and its potential for growth is the highest among all sectors in the healthcare market. It is valued at Rs. 50,026 crore for 2018-19 and is expected to reach to Rs. 86,840 crore by 2021-22. India depends on imports up to an extent of 85 per cent of total domestic demand of medical devices.

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Union Cabinet scheme on Promotion of Bulk Drug Parks

• The scheme on Promotion of Bulk Drug Parks for financing Common Infrastructure Facilities in 3 Bulk Drug Parks with financial implication of Rs. 3,000 crore for next five years.

• Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical KSMs/Drug Intermediates and APIs in the country with financial implications of Rs6,940 crore for next eight years.

Details:

Promotion of Bulk Drug Parks

• Decision is to develop 3 mega Bulk Drug parks in India in partnership with States.

• Government of India will give Grants-in-Aid to States with a maximum limit of Rs. 1000 Crore per Bulk Drug Park.

• Parks will have common facilities such as solvent recovery plant, distillation plant, power & steam units, common effluent treatment plant etc.

• A sum of Rs. 3,000 crore has been approved for this scheme for next 5 years.

Related Projects: - Active Pharma Ingredients (API)

Production Linked Incentive Scheme

• Financial incentive will be given to eligible manufacturers of identified 53 critical bulk drugs on their incremental sales over the base year (2019-20) for a period of 6 years.

• Out of 53 identified bulk drugs, 26 are fermentation based bulk drugs and 27 are chemical synthesis based bulk drugs.

• Rate of incentive will be 20 % (of incremental sales value) for fermentation based bulk drugs and 10% for chemical synthesis based bulk drugs.

• A sum of Rs. 6,940 crore has been approved for next 8 years.

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Key players

Alpha Remedies Ltd.

Ankur Drugs & Pharma Ltd.

Aurobindo Pharma Ltd.

Cian Healthcare Ltd

Cipla Ltd.

Dr. Reddy'S Laboratories Ltd.

Farmson Pharmaceutical Gujarat Pvt. Ltd.

Glaxosmithkline Pharmaceuticals Ltd.

Indoco Remedies Ltd.

Pan Drugs Ltd.

Piramal Enterprises Ltd.

Sanofi India Ltd.

Sri Krishna Pharmaceuticals Ltd.

Teva Pharmaceutical & Chemical Inds. India Pvt. Ltd.

Triton Laboratories Ltd.

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