Context:
The Indian government has recently taken decisive action by banning the production and export of drugs containing Tapentadol and Carisoprodol after reports emerged that unapproved combinations of these drugs were being exported to West African countries. The Central Drugs Standard Control Organisation (CDSCO) conducted an audit at Aveo Pharmaceuticals in Mumbai and found regulatory violations, leading to an immediate halt in operations at the company.
About Tapentadol and Carisoprodol:
Tapentadol is a prescription opioid analgesic used to treat moderate to severe pain, altering the way the brain and nervous system perceive pain. It shares properties with certain antidepressants and is tightly regulated due to its potential for misuse.
Carisoprodol is a muscle relaxant used for treating muscle spasms and discomfort linked to acute musculoskeletal conditions. It is typically prescribed alongside rest and physical therapy to aid recovery.
While both drugs are approved individually in India, their combination is not authorized. Despite this, unapproved formulations were being exported, raising concerns about safety, efficacy, and regulatory oversight.
Key Concerns:
1. Opioid Crisis in West Africa:
o The unregulated export of these drug combinations was contributing to the opioid crisis in the region.
o Without proper oversight, these drugs pose a serious risk of addiction and health hazards.
2. Regulatory Lapses:
o The illegal export of unapproved drug combinations highlights loopholes in regulatory enforcement.
o Despite stringent laws under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, unethical manufacturing and export practices were ongoing.
About the Central Drugs Standard Control Organisation (CDSCO):
· The CDSCO is India's national regulatory authority for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices.
· It was established under the Drugs and Cosmetics Act, 1940, and is responsible for regulating manufacturing, import, and sale of pharmaceuticals.
· Its functions include approving new drugs, conducting clinical trials, setting drug standards, monitoring imported drug quality, and coordinating with state regulatory bodies.
· Headquartered in New Delhi, the organization is led by the Drugs Controller General of India (DCGI) and operates multiple zonal, sub-zonal, port offices, and laboratories across the country.
Way Forward:
The Indian government’s crackdown underscores its commitment to preventing pharmaceutical misuse and ensuring public safety. Immediate actions—including halting production, suspending exports, and seizing unapproved drugs—are crucial to preventing further harm.
Industry experts have supported the ban, emphasizing that this combination was unapproved globally, and its prohibition will likely deter unethical pharmaceutical practices.
To strengthen regulatory oversight, CDSCO has recommended updating the Export No Objection Certificate (NOC) checklist, making it mandatory for drugs to have approval from both India and the importing country before export.
By tightening regulations and enhancing compliance, India is reinforcing its role as a responsible global pharmaceutical exporter, ensuring that public health and safety remain a priority.
