The United States health authorities, the Centers for Disease Control and Prevention (CDC), along with the Food and Drug Administration (FDA), have expressed concern over a particular strain of drug-resistant bacteria that has been linked to eye drops imported from India. The Drugs Controller General of India (DCGI) has reached out to the U.S. FDA to learn more about this issue. Amidst these concerns, Global Pharma Healthcare has decided to recall its EzriCare eye drops from the U.S. market and cease the production of ophthalmic products until further notice.
Investigation on the Alleged Contamination
Initial reports from India’s Health Ministry point towards possible contamination being sourced from bottles that were opened in the U.S., rather than from the production company. Samples collected from Global Pharma Healthcare did not show signs of any contaminations. Until the investigation is concluded, the company has chosen to halt all manufacturing processes related to ophthalmic products.
The Status of the Indian Pharmaceutical Sector
India holds a significant position in the global pharmaceuticals industry. By volume, it ranks third worldwide and comes 14th when considering value. The nation leads the pack in terms of providing generic medicines on a global scale, accounting for a fifth of the worldwide supply by volume. India’s prowess extends to vaccine manufacturing too, where it stands as a top provider.
The Indian pharma sector boasts of over 3,000 companies, making use of more than 10,500 manufacturing facilities across the nation. It is also known for its extensive, highly skilled workforce.
Past Instances of Concern
This isn’t the first time Indian pharmaceutical products have come under scrutiny. Earlier in 2022, the World Health Organization (WHO) had issued an alert about four cough syrups manufactured in India. These syrups were implicated in cases of acute kidney injury amongst children and were also linked to 66 fatalities in The Gambia, a small West African nation.
About the Drugs Controller General of India (DCGI)
The DCGI heads the Central Drugs Standard Control Organization (CDSCO) which functions under the Ministry of Health and Family Welfare. The CDSCO’s mandate includes approving licenses for certain categories of drugs, including blood and blood products, IV fluids, vaccines, and sera within India.
The DCGI is charged with setting manufacturing, sales, import, and distribution standards for drugs and medical devices in India. It also ensures uniform enforcement of the Drugs and Cosmetics Act,1940. Furthermore, the DCGI functions as an appellate authority in disputes related to drug quality and maintains the national reference standard for drugs. Under the Medical Device Rules 2017, the DCGI has the authority to issue licenses for relevant medical devices.
