Key Summary
- The closure of these units, which account for drugs worth £6.29 billion, may cause a shortage
- This may affect the availability of antibiotics, anti-hypertensives, anti-inflammatory medicines, diabetes drugs and general medicines
- India is the foremost supplier of generic drugs worldwide, accounting for 20 percent of mediciness
With the deadline for good manufacturing practices (GMP) approaching, more than 60 percent of India's 8,500 registered small and medium-sized pharmaceutical units risk closure, according to The Economic Times.
On December 31, drug companies with an annual turnover below £20.99 million are mandated to implement GMP. For large companies, these norms came into effect on June 28, 2024.
According to the revised Schedule M norms under the Drugs and Cosmetics Act, these companies must align with WHO standards and establish stringent requirements for facilities, processes, documentation, and personnel.
The new norms are aimed at ensuring consistent production and quality control, product effectiveness, and curbing the menace of fake drugs.
However, most of these small units operate from single facilities, and industry watchers say they are unlikely to meet the deadline.
The closure of these units, which account for drugs worth £6.29 billion, may cause a shortage of commonly used drugs, leading to job losses, and impact the medicine security of countries that import drugs from India.
Market experts claim this could affect the availability of antibiotics, anti-hypertensives, anti-inflammatory medicines, analgesics, cough and cold tablets, diabetes drugs, and general medicines.
Many of these small drug makers are based in Maharashtra, Gujarat, Himachal Pradesh, and Andhra Pradesh states.
The state regulators were asked to conduct periodic inspections and submit monthly reports.
According to the Indian government's estimates, the country's pharmaceutical market was valued at an estimated $50 billion in FY 2023-24, with domestic consumption accounting for $23.5 billion.
Globally, India's pharmaceutical industry stands as the third largest by volume and the 14th largest by value.
It is the foremost supplier of generic drugs worldwide, contributing approximately 20 percent of the global supply.
This encompasses the production of around 60,000 generic brands across 60 therapeutic categories.
Key segments within this robust industry include generic drugs, over-the-counter medications, bulk drugs, vaccines, contract research & manufacturing, biosimilars, and biologics.
