Pharmaceutical Industry in India

What’s in today’s article?

• Why in news?
• The pharmaceutical industry in India
• Notable achievements
• Industry scenario
• News Summary: Adopt WHO-standard good manufacturing practices- Govt sets deadline for pharmas
• What are the Instructions given by the government pharmaceutical industries?
• Significance of this step

 

Why in news?

• The government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) in India pharmaceutical industries.
  •  GMP are a set of quality management and regulatory guidelines.
  • These are designed to ensure the consistent production of safe, high-quality products, especially in industries such as pharmaceuticals, food and beverages, cosmetics etc., where product quality and safety are critical.
  • The primary goal of GMP is to minimize risks that can arise from errors, contamination, or deviations during the manufacturing process.
  • In India, GMP were revised in 2018, bringing them on par with World Health Organisation (WHO) standards.
• This was after the incidents of several countries reporting deaths allegedly linked to contaminated India-manufactured drugs.

 

The Pharmaceutical Industry in India

Notable achievements

• The Indian Pharmaceuticals industry plays a prominent role in the global pharmaceuticals industry. 
• India ranks 3rd worldwide for production by volume and 14th by value.
• India is the largest provider of generic medicines globally, occupying a 20% share in global supply by volume.
  • The pharmaceutical industry in India offers 60,000 generic brands across 60 therapeutic categories.
• It is the leading vaccine manufacturer globally. 60% of the world’s vaccines comes from India.

 

Industry scenario

• Foreign Direct Investment (FDI)
  • 100% FDI in the Pharmaceutical sector is allowed under the automatic route for greenfield pharmaceuticals.
  • 100% FDI in the pharmaceutical sector is allowed in brownfield pharmaceuticals; wherein 74% is allowed under the automatic route and thereafter through the government approval route.
• Market Size
  • The pharmaceutical industry in India is currently valued at $50 bn. It is expected to reach $65 bn by 2024 and to $120 bn by 2030.
• Export
  • India is a major exporter of Pharmaceuticals, with over 200+ countries served by Indian pharma exports. 
  • India supplies over 50% of Africa’s requirement for generics, ~40% of generic demand in the US and ~25% of all medicine in the UK.
  • For the period 2021-22, export of drugs and pharma products stood at $24.6 bn compared to $24.44 bn as of 2020-21. 
  • The Indian pharma industry witnessed exponential growth of 103% during 2014-22 from $11.6 bn to $24.6 bn.
• Support by the govt
  • The Indian pharmaceuticals market is supported by the following Production Linked Incentive (PLI) Schemes.
  • PLIs are aimed to boost domestic manufacturing capacity, including high-value products across the global supply chain.

 

News Summary: Adopt WHO-standard good manufacturing practices- Govt sets deadline for pharmas

What are the Instructions given by the Government Pharmaceutical Industries?

• Deadlines set
  • Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months.
  • However, medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year.
  • Those who do not comply with the direction will face suspension of licence and/ or penalty.
• Introduction of a GMP-related computerised system
  • The companies will also have to introduce a GMP-related computerised system. 
  • These computer programmes will be designed to automatically record all the steps followed and checks done, which will ensure all the processes are followed.
• Carry out stability studies as per the climate conditions
  • The companies will also have to carry out stability studies as per the climate conditions. 
  • At present, most companies store their samples under recommended conditions and test for various parameters from time to time. 
  • Now, they will have to keep the drugs in a stability chamber, set the proper temperature and humidity, and carry out an accelerated stability test as well.
• Requirement for companies involved supplying medicines to domestic/foreign markets
  • Currently, companies exporting medicines to other countries already have to be WHO-GMP certified. 
  • However, those manufacturing medicines for the domestic market can be granted permission if they meet the requirements listed in Schedule M of rules under the Drugs and Cosmetics Act. 
    • Among other things, this lists the specifications of the manufacturing units, processes that need to be followed, and equipment needed.

 

Significance of this step

• For better quality control
  • Currently, 2,000 of the 10,500 manufacturing units in the country have been found to be compliant with the global WHO-GMP standards. 
  • Now, all will have to implement the revised GMP, ensuring quality medicines for the domestic market and abroad.
• Risk-based inspection had pointed out found several deficiencies
  • Recently, a risk-based inspection of 162 manufacturing units and 14 testing labs found several deficiencies.
  • This included absence of testing of raw materials before use, absence of quality failure investigation of its products, faulty design of manufacturing and testing areas.
  • The recent instructions by the government would lead to at least 11 specific changes in the manufacturing process on the ground.
    • This includes introduction of a pharmaceutical quality system, quality risk management, product quality review, and validation of equipment.
• India’s image as the pharmacy of the world
  • Indian pharma industry is facing a credibility crisis.
    • The WHO, in October 2022, said that the deaths of dozens of children in Gambia and Uzbekistan were due to contaminated cough syrups manufactured by Indian drugmakers.
    • In February 2023, blindness, severe eye infections and a death in the US were linked to India-made eye drops.
  • In this context, the recent instructions would help restore India’s image as the pharmacy of the world.

 

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Q1) What are Good Manufacturing Practices (GMP)?

 GMP are a set of quality management and regulatory guidelines. These are designed to ensure the consistent production of safe, high-quality products, especially in industries such as pharmaceuticals, food and beverages, cosmetics etc., where product quality and safety are critical.The primary goal of GMP is to minimize risks that can arise from errors, contamination, or deviations during the manufacturing process.

 

Q2) What is FDI?

FDI stands for "Foreign Direct Investment." It is an investment made by a person, organization, or entity from one country (referred to as the "home country") into a business or entity located in another country (referred to as the "host country"). FDI involves a direct ownership stake in the foreign business, which can take the form of acquiring shares in a company, setting up subsidiaries or branches, or investing in joint ventures with local partners.

 

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Source: Adopt WHO-standard good manufacturing practices: Govt sets deadline for pharmas | Invest India | Times of India