Issues with India’s Pharmaceutical sector

Why in the News?

USFDA has issued a warning letter to a Gujarat-based Pharma manufacturing company citing serious violations of Good Manufacturing Practices (GMP).

India’s Pharma Sector:

1. Indian pharma sector is set to achieve $130 billion by value, in the year 2030.
2. The domestic Pharma companies are expected to report a steady revenue growth of 6-8 per cent in 2023-24.
3. India is known as ‘the Pharmacy of the world’ as it is the world's third largest manufacturer of drugs by volume and second largest by value and known for its generic medicines and low-cost vaccines.
4. India accounts for 60 percent of global vaccine production, contributing 40-70% of the WHO demand for DPT and BCG vaccines, and over 90% of the measles vaccine.
5. The Exports of Pharmaceuticals have registered an increasing trend continuously for the past years.

Major segments of Indian Pharmaceutical Industry:

Challenges faced by the Pharma sector of India:

1. Rising pressure from the US FDA:
   1. In 2018, USFDA inspections of Indian pharma manufacturing companies accounted for 14% of total FDA inspections across the world.
   2. Between 2013-18, 60 Drug good Manufacturing practices warning letters have been issued. This can potentially lead to,
      1. Negative impact on the share market value of Indian Pharma Companies.
      2. Hampering of the overall image of the pharma manufacturing quality.
2. Government’s stringent control over the pricing of drugs turns out be a hurdle for the growth of innovative capabilities of Pharma companies, as the companies will restraint to invest in R&D activities as the assurance of getting the investment back through sale of drugs become bleak.
3. Spurious drugs
   1. WHO reports that 35% of the world’s spurious drugs are produced in India, that are fake, counterfeit, or substandard.
   2. Gambia has made it mandatory for all Indian drugs to be tested before being exported to the African country since July 1, after Gambia reported death of dozens of children linked to consumption of cough syrup from India.
4. Lack of skilled workforce:
   1. Gap between the theoretical degree studies and actual requirements of the industry, leading to a skill gap in spite of the fact that 4 lakh Pharma students graduate every year.
   2. This leads to sub-optimal utilisation and efficiency of the manpower.
   3. This also leads to Good Manufacturing Practices issues in the manufacturing processes.
5. India’s high dependence on China for APIs:
   1. About 80% of India’s Active Pharmaceutical Ingredients’ (APIs), the raw materials used in the manufacture of medicines or formulations, requirements are fulfilled through imports from China.

Initiatives taken by India:

1. PLI Scheme for Pharmaceuticals
   1. The scheme aims to enhance India’s manufacturing capabilities by increasing investment and production in the sector. This shall result in product diversification to high-value goods in the pharmaceutical sector.
   2. The scheme covers pharmaceutical goods under the following three categories-
      1. Category 1:

Biopharmaceuticals, Complex generic drugs, Patented drugs or drugs nearing patent expiry, Cell-based or gene therapy drugs, Orphan drugs, Special empty capsules, Complex excipients, Phyto-pharmaceuticals and other drugs as approved.

1. 1. 2. Category 2:

Active Pharmaceutical Ingredients, Key Starting Materials and Drug Intermediates

1. 1. 3. Category 3
         1. This includes Drugs not covered under Category 1 and Category 2.

Repurposed drugs, Auto-immune drugs, anti-cancer drugs, anti-diabetic drugs, anti-infective drugs, cardiovascular drugs, psychotropic drugs and anti-retroviral drugs, In-vitro diagnostic devices and other drugs not manufactured in India.

2. Umbrella Scheme for Development of Pharmaceutical Industry
   1. A Central Sector Scheme namely ‘Strengthening of Pharmaceuticals Industry’ with three sub-schemes
      1. Assistance to Pharmaceutical Industry for Common Facilities (API-CF)
      2. Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)
      3. Pharmaceutical & Medical Devices Promotion and Development Scheme (PMPDS)
   2. The scheme intends to increase the efficiency and competitiveness of domestic pharmaceutical and MedTech industry in the global market.
   3. Also, to ensure accessibility, availability and affordability of quality pharmaceuticals and medical devices for mass consumption.
3. Promotion of Bulk Drug Parks scheme
   1. Aims for creation of world class common infrastructure facilities to bulk drug units located in the parks.
   2. The Bulk Drug parks can
      1. bring down the manufacturing cost
      2. Increase competitiveness of the domestic bulk drug industry
      3. Minimize country’s dependence on imports by providing a push to indigenous manufacturing and facilitate Indian bulk drug industry.
4. Establishment of Pharma Bureau
   1. Provides facilitation to investors and resolves issues of inter-departmental coordination in the Pharmaceutical and Medical Device sector.
   2. It also policy support to Department of Pharmaceuticals for framing incentive schemes for the industry.