The Active Pharmaceutical Ingredient (API) is the part of any drug that produces the intended effects. Some drugs, such as combination therapies, have multiple active ingredients to treat different symptoms or act in different ways.
Production of APIs has traditionally been done by the pharmaceutical companies themselves in their home countries. But in recent years many corporations have opted to send manufacturing overseas to cut costs. This has caused significant changes to how these drugs are regulated, with more rigorous guidelines and inspections put into place.
Cefalexin, is an antibiotic that can treat a number of bacterial infections. It kills gram-positive and some gram-negative bacteria by disrupting the growth of the bacterial cell wall. Cefalexin is a beta-lactam antibiotic within the class of first-generation cephalosporins. It works similarly to other agents within this class, including intravenous cefazolin, but can be taken by mouth. Cefalexin can be used in those who have mild or moderate allergies to penicillin. However, it is not recommended in those with severe penicillin allergies.
Ampicillin is an antibiotic used to prevent and treat a number of bacterial infections, such as respiratory tract infections, urinary tract infections, meningitis, salmonellosis, and endocarditis. It may also be used to prevent group B streptococcal infection in newborns. It is used by mouth, by injection into a muscle, or intravenously. Like all antibiotics, it is not useful for the treatment of viral infections. Ampicillin is used to treat infections by many Gram-positive and Gram-negative bacteria. It was the first "broad spectrum" penicillin with activity against Gram-positive bacteria, including Streptococcus pneumoniae, Streptococcus pyogenes, some isolates of Staphylococcus aureus (but not penicillin-resistant or methicillin-resistant strains), Trueperella, and some Enterococcus.
Paracetamol (acetaminophen) is a pain reliever and a fever reducer. The exact mechanism of action of is not known. Paracetamol is used to treat many conditions such as headache, muscle aches, arthritis, backache, toothaches, colds, and fevers. It relieves pain in mild arthritis but has no effect on the underlying inflammation and swelling of the joint. Paracetamol is generally safe at recommended doses. The recommended maximum daily dose for an adult is three to four grams. Higher doses may lead to toxicity, including liver failure. Serious skin rashes may rarely occur. It appears to be safe during pregnancy and when breastfeeding. In those with liver disease, it may still be used, but in lower doses. It is classified as a mild analgesic. It does not have significant anti-inflammatory activity. How it works is not entirely clear.
Ibuprofen is a medication in the nonsteroidal anti-inflammatory drug (NSAID) class that is used for treating pain, fever, and inflammation. This includes painful menstrual periods, migraines, and rheumatoid arthritis. It may also be used to close a patent ductus arteriosus in a premature baby. It can be used by mouth or intravenously. It typically begins working within an hour
India's reliance on pharma ingredient imports has risen over the past few decades due to the higher cost of domestic production, with the price gap reaching as much as 20%-30%, particularly for energy-intensive fermentation-based ingredients used in anti-infectives. Import dependence is more than 90% for some life-saving drugs, including penicillin and ciprofloxacin.
India is the seventh largest country in the world and has the second highest population. It has a parliamentary democratic form of government and has abundant natural resources and sufficient oil reserves. The country has a huge skilled, English-speaking, and inexpensive labor force. Its young population and current economic policies have made it one of the largest recipients of FDI in the world.
Asia Pacific is expected to be the fastest-growing market over the forecast period. Owing to the availability of affordable labor, major companies in the market are setting up API manufacturing plants in developing countries such as China and India.
The global demand of APIs include ageing population, rising expenditures on healthcare, increasing prevalence of lifestyle diseases, etc. Looking forward, the market value is projected to reach US$ 258.8 Billion by 2025, exhibiting a CAGR of 5.6% during 2020-2025. The API market is competitive in nature and is becoming increasingly competitive. Consequently, manufacturers are required to enhance products in order to gain advantage over previously marketed products.
The emergence of COVID-19 has brought the world to a standstill. We perceive that this health crisis has brought an unprecedented impact on businesses across industries. However, this too shall pass. Rising support from governments and several companies will help within the fight against this highly contagious disease. There are some industries that are struggling and some are thriving. Overall, almost each sector is anticipated to be impacted by the pandemic.
The government also notified a scheme to promote bulk drug parks. For selected parks, financial assistance to the tune of 70 per cent of the project cost of common infrastructure facilities will be provided. In the case of Northeast states and hilly states (Himachal Pradesh, Uttarakhand, Union Territory of Jammu & Kashmir, and Union Territory of Ladakh), financial assistance will be 90 per cent of the project cost. The maximum assistance under the scheme for one bulk Drug Park will be limited to Rs 1,000 crore. The total financial outlay of the scheme is Rs 3,000 crore.
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.
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.
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.
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.
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.
Few Indian major players are as under
Alpha Remedies Ltd.
Ankur Drugs & Pharma Ltd.
Aurobindo Pharma Ltd.
Cian Healthcare Ltd
Dr. Reddy'S Laboratories Ltd.
Farmson Pharmaceutical Gujarat Pvt. Ltd.
Glaxosmithkline Pharmaceuticals Ltd.
Indoco Remedies Ltd.
Pan Drugs Ltd.
Piramal Enterprises Ltd.