Tags: Indian pharmaceuticals, drug quality, global market, counterfeit drugs, biosimilars, India-US-China trade
India’s Race to Improve Pharma Standards
India’s pharmaceutical industry is under pressure to improve its quality control as it seeks to expand its global market share. In recent years, the country has been involved in several controversies, including the deaths of at least 141 children due to toxic cough syrups linked to Indian manufacturers. According to the World Health Organization (WHO), contaminated products from India were found in at least 15 countries.
The country’s drug manufacturers have been tasked with aligning their practices with the WHO’s Good Manufacturing Practices (GMP), and they have until the end of the year to meet these standards. This overhaul could allow more small and medium-sized enterprises to enter the export market. However, some local firms are requesting an extension due to the financial and logistical challenges involved in upgrading their processes.
Counterfeit, Adulterated, and Substandard Drugs
Experts cite three major issues plaguing India’s pharma industry: counterfeit drugs, adulterated medicines, and substandard quality. The country was recently rocked by a scandal involving fake antibiotics sold to government hospitals, with ingredients like talcum powder and starch used instead of proper pharmaceutical components.
This follows a troubling pattern, as India’s local manufacturers have been involved in multiple cases of producing substandard drugs. One infamous example was the use of diethylene glycol in cough syrups, a substance toxic to humans, which caused the deaths of children in both India and abroad.
Pressure on Local Manufacturers
Around 88% of India’s pharmaceutical companies are micro, small, and medium enterprises (MSMEs). These companies often face intense competition, which leads them to cut costs, sometimes at the expense of quality. To keep production costs low, some manufacturers opt for cheaper materials or fail to conduct thorough quality tests throughout the production process.
Furthermore, there is a shortage of drug inspectors and testing facilities in India. Regulatory bodies are often understaffed, and laboratories are struggling to keep up with the growing number of tests required.
India’s Pharma Industry Still Booming
Despite these issues, India’s pharmaceutical sector is projected to grow rapidly, with expectations that the industry will double in value by 2030. Known as the “pharmacy of the world,” India is the third-largest drug manufacturer by volume and the world’s largest supplier of generic drugs.
India also manufactures half of the world’s vaccine doses, and its pharma exports are on the rise. With geopolitical tensions between the US and China, India has a chance to further establish itself in the global market by supplying high-quality drugs to international markets.
Geopolitical Shifts Create Opportunities
The ongoing US-China trade rivalry has prompted concerns over the reliability of China as a supplier of pharmaceutical ingredients. The US recently passed the Biosecure Act, which restricts American companies from working with certain Chinese pharmaceutical manufacturers due to biosecurity concerns. This presents India with a unique opportunity to fill the gap in the global supply chain if it can improve the quality of its pharmaceutical products.
India’s pharmaceutical industry boasts about 650 USFDA-approved plants, the highest number outside the US, which allows it to supply high-quality drugs for export. However, products made for the domestic market still face issues with quality control and safety.
Striving for Innovation and Talent Development
To remain competitive, India’s pharma industry must invest more in research and development, particularly in biologics and biosimilars, which are the future of medicine. China, a global leader in biotech patents and research, has already gained an edge in this area.
India’s capacity to produce biosimilars and biologics remains limited, and its research and development investment lags behind that of other countries. The country also faces a shortage of skilled talent, with many pharmaceutical companies hiring staff without formal pharmaceutical training to save costs.
Challenges to Meeting Global Standards
Despite the revision of Schedule M rules to align with global standards, India’s pharma industry faces significant hurdles. For one, there are over 10,000 drug manufacturers in India, but only around 2,000 are compliant with WHO’s GMP. Smaller companies, in particular, are struggling to meet the new quality requirements and are petitioning for more time to comply.
Even if India manages to meet these standards, experts caution that it may not be enough to secure its place as a global pharma leader. Without a focus on innovation and talent development, India risks being outpaced by competitors in the rapidly evolving biopharmaceutical industry.
The Road Ahead
India’s pharmaceutical industry is booming, but significant challenges remain. Regulatory reforms are necessary, but without stronger enforcement and investment in new technologies and talent, India’s pharmaceutical ambitions may fall short. While it may be labeled the “pharmacy of the world,” the reality on the ground suggests that much more work is needed to ensure that India can truly claim this title on the global stage.
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