What is Pharmaceutical Industry | Current Pharma Industries and their Technology

Pharmaceutical Industry

Introduction 

Indian Pharmaceutical industry is the third-largest in the world and is one of the most developed countries in the Pharmaceutical industry. Indian Pharma industry is driven by generic drug production. Generic drugs can be manufactured by companies other than the one inventing company. It is often called the "Pharmacy of the World". Today Indian pharmaceutical industry is recognized as a global leader in the production of high-quality generic drugs.

World Health Organisation (WHO), World Intellectual Property Organisation (WIPO), Pan American Health Organisation (PAHO), World Trade Organisation (WTO) and International Conference of Harmonization (ICH) is an organization which plays an essential role in all aspects of Pharmaceutical Regulation. It may be related to Drug product registration, manufacturing, distributing, price control, intellectual property protection, R&D, and marketing.

The pharmaceutical industry is engaged with the manufacturing of API, Drugs, and Medical Devices. Regulatory agencies in a few of the Countries are in the following table.

Countries with their Regulator Agency

Many Indian Pharma companies are trying to innovate and making new drugs. Recently, India is also becoming a sought-after off-shoring destination for several functions such as R&D and business services, in the Pharmaceutical fields. Several big pharma companies are opening in India to reduce the cost of drugs and developing them.

Current Pharma Industry

• Discovery and Development
• Manufacturing Sector
• Marketing Sector
• Availability Sector

1) Discovery and Development

In 1922, The first modern synthetic drug for India was developed by UN Brahmachari against Urea Stibamine and it was a life-saving drug for a large section of the population. That was a new start of Discovery and Development in India. From the seminal discovery of UN Brahmachari, the pharmaceutical industry in India grew very significantly. 

India was a favorite destination for “Chemistry” outsourcing (GVK, Syngene, Chembiotek, etc.).

2) Manufacturing Sector

Indian pharmaceutical sector is expected to grow to US $100 billion, while the medical device market is expected to grow the US $25 billion by 2025. Continuous pharmaceutical manufacturing offers potential flexibility, quality, and economic advantages both in process development and manufacturing.

3) Marketing Sector

Pharma company needs to obtain a drug license from the State drug control department and GST registration for Marketing Sector.  A Pharma company appoints C & F, super distributor, distributor, franchise, stockist, medical representative, etc. For more profit, Indian Medical Representative goes to Clinics, Medical, or Shops and convinces them to take purchase there product.

4) Availability Sector

The Health system needs to be strengthened by making essential medicines available for patients. Ensuring access to free medicines is likely to reduce private expenditure on medicines. India's total number of government hospital are 10,628 estimated in 2016. And 11,810 Private Hospital. The number of Registered practitioners are 840,000 in India.

Different Department in Pharmaceutical Industry

1) Purchase Department

2) Store "RM & PM"

3) R & D, ADL

4) Technology Transfer

5) Production and Packaging

6) Quality Control

7) Quality Assurance

8) Regulator Affairs Department

9) Maintenance

10) HR Department

1) Purchase Department

Roles of the Purchase Department in Pharmaceutical Industries are: Is the List of TSE/BSE certificate available? Checking the vendor approval process. Are all the approval Qualification as per SOP? and Checking the number of vendors against for material.

2) Store "RM & PM"

Roles of Store in the Pharmaceutical Industry are Cleaning and Operation procedure, Operation of dispensing Booth and Growing procedure in the Dispensing Room, etc

3) R & D Department

Jobs available in the R&D department are very less. The work of the R&D Department is Innovative activities undertaken by corporations or governments in developing new services or products.

4) Technology Transfer

Formal technology transfer involves the outright procurement of technology through its sale, licensing all acquisition of the enterprise in which Technology is embedded. Purchased ready technology is found to be a good substitute for R&D activities. In developing countries, the import of Technology is more frequent, although firms located in industrialized countries to purchase Technology.

5) Packaging

Packaging includes Primary Packing, Secondary Packing, and Tertiary Packing.

In Primary Packing, the Tablets and The Medicine are kept in an open environment (Direct Contact With Medicine). The Temperature of the Environment needs to maintain.

In Secondary Packing, the medicines are covered with the Show Box.

In Tertiary Packing, after covering of Medicine by Show Box, The Medicine are packed in bundles.

6) Quality Control Department

role of the Quality Control Department in the Pharmaceutical industry is to maintain the quality of Medicines. In the quality control department, only those people get jobs who are Graduated in Pharmacy.

7) Quality Assurance Department

There is a Quality Assurance Department that keeps care of the assurance of medicines. in other words, we can say that to maintain the quality of medicines. The quality Control Department and Quality Assurance Department are not too much different from each other.

8) Regulatory Affairs Department

All the documentation work, patent work, copyright issue, Trade Mark, and much other legal work are done by the Regulator Affairs Department.

9) Maintenance Department

The role of the maintenance department in the Pharmaceutical Industry is to design and construct a facility system, operation of the system, Energy Management, Technology, and regulatory compliance.

10) HR Department

The role of the HR Department in the Pharmaceutical Industry is to manage the jobs, interviews, and documents of new employees.

Future of Indian Pharmaceutical Industry

The future of the Indian Pharma Industry is quite bright. Even the Government of India has made several augment to the growth of the Pharma Industry. In the current scenario, it is an opportunity and a crisis at the same time. About 70% of the top companies are Indian owned.

India has a total of 24,000 pharmaceutical companies, of which around 250 falls under the organized category. Some of them are Alembic Chemicals, Aurobindo Pharma, Sun Pharmaceuticals, Ranbaxy Laboratories, Torrent Pharma, Ambalal Sarabhai Limited, Cadila Healthcare, Cipla, Dr. Reddy’s, IPCA Laboratories, Kopran, Lupin Labs, Lyka Labs, Nicholas Piramal, Matrix Laboratories, Orchid Chemical and Pharmaceuticals, TTK Healthcare, Unichem Labs, and Wockhardt.

Boycott of China?

Because of recent political tensions between India and China. India had made a decision to Boycott Chinese APIs from India. Such a possible move is a major cause of concern for India's pharmaceutical industry as well as for people in India, and globally.

China has a very high market share in India. Boycotting Chinese apps and Chinese companies was a very important decision for India. 80% of India's mobile phones are made in China. And 70% of India's Pharmaceutical Industry was dependent on China.

The 1970 Indian Patient Act, which removes product patience in pharmaceuticals, is widely lauded for facilitating the growth of India's industry.

China’s Active Pharmaceutical Ingredient (API)

India is the third-largest producer of finished drugs in the world. 70% of APIs in India are supplied from China. Boycotting Chinese API would affect the Indian pharmaceutical industry.

An estimated 70% of API requirements of India's Pharmaceutical industries are source from China. For some drugs, such as paracetamol and ibuprofen.

In 2017, The value of India's pharmaceutical industry was 33 Billion US dollars. And almost 20% of the value was of generic drugs. In 2018, the turnover value of India's pharmaceutical industry was 18.12 US Billion Dollars. This means it was increased by 10%. India's Pharmaceutical Industry is a growing industry. Banning China's APIs directly will affect the Indian Pharmaceutical industry.

Technology

A serve contraction of Indian Pharmaceutical production and it's almost $20 Billion worth of annual exports, cold affect access to medicines both in India and Globally. The impact will be essentially high in low and medium-income countries which had become increasingly dependent on affordable medicines supplied by India. 80% of India's Company's Instruments are made in China. And 70% of India's Pharmaceutical Industry was dependent on China.

By early 1980, the market share of foreign-owned multinational fell from 90% in 1972 to 50% dramatically in India. Also, the price of medicines in India fell from being amongst the highest in the world to amongst the lowest. India also benefited from the 1973 Foreign Exchange Regulation Act and the Subsequent New Drug Policy (1978), which restricted the activities of foreign multinationals in the country. The pharmaceutical sector in India, expected to expand at a CAGR of 22.4 percent over 2015–20.

Conclusion

The conclusion which comes out from the study is that due to the amendment patent Act 2005, Indian pharmaceutical companies have been increased their research and development activity by 10% to 15%. China's export to India in 2019 was the US $68 billion and India's exports to China are USD 16.96 billion, India has a trade deficit with China of US $50 billion which is gradually decreasing.

The Export of Medicines from India was the US $15,742,437,326 in 2019. And 11th World Rank. In 2019 the Largest Medicine Export was from Germany US $ 89,754,623,949, Which is thrice the Export of India’s.

The above stats show the Top 10 Countries with the Largest Medicine Export. China created a low-cost APIs manufacturing industry. In Exporting Medicines, China is not too far from India. Both countries export the same amount of Medicines to other Countries. When we talk about the value of the Global Pharmaceutical Market. USA stands first with the US $339,462 and China stands on 3rd position with the US $86,850. In Pharmaceutical Market, the Indian Rank is too low (Not even in the top 10). 

But hope the Indian Government will invest more in the Pharmaceutical Industry and Make it one of the most famous Industries. The Government of India has made several augment to grow Pharma Industry.