Health Secretary Calls for Stronger Regulatory Standards to Ensure Quality Medicines

Feb 25, 2025

Pharmaceutical Regulatory Standards, India Drug Control Measures, DCGI Pharmaceutical Oversight, Quality Assurance in Medicines, Indian Pharma Compliance
Pharmaceutical Regulatory Standards, India Drug Control Measures, DCGI Pharmaceutical Oversight, Quality Assurance in Medicines, Indian Pharma Compliance

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Union Health Secretary Punya Salila Srivastav has emphasized the need for stronger regulatory standards to ensure that only high-quality and effective medicines circulate in India. Addressing state drug regulators at a meeting on Monday, she urged officials to strictly enforce prescription-based sales to prevent the illicit diversion of narcotic and psychotropic drugs.

Key Highlights:
Call for Stricter Drug Regulation:

  • State drug regulators must ensure that medicines are dispensed only through valid prescriptions to prevent misuse and illegal drug trafficking.

  • Strengthening regulatory oversight is essential to protect public health and curb substance abuse, aligning with the Nasha Mukt Bharat Abhiyan initiative.

Nationwide Crackdown on Illicit Drug Use and Manufacturing:

  • Srivastav commended the Central Drugs Standard Control Organisation (CDSCO) and state regulators for completing risk-based inspections of 905 drug manufacturing and testing firms.

  • These inspections resulted in 694 enforcement actions, demonstrating a firm stance against non-compliant pharmaceutical practices.

Backdrop of Opioid Crisis and Regulatory Action:

  • The meeting follows the Drugs Controller General of India (DCGI)'s ban on the production and export of tapentadol-carisoprodol drug combinations, which were linked to an opioid crisis in West Africa.

  • A Mumbai-based pharma company was found to have exported unapproved formulations of these drugs, leading to international concerns over India's pharmaceutical exports.

Statements from Officials:
Union Health Secretary, Punya Salila Srivastav:
“Regulatory standards need to be strong to ensure that only quality and effective medicines circulate in the country. State regulators must enforce prescription-based sales to prevent drug trafficking and illicit substance abuse.”The Indian government is stepping up pharmaceutical oversight, aiming to strengthen drug regulation, prevent narcotic misuse, and ensure compliance with international safety standards. More inspections and enforcement actions are expected, as authorities work to safeguard public health and India's pharmaceutical reputation globally.

Pharmaceutical Regulatory Standards
India Drug Control Measures
DCGI Pharmaceutical Oversight
Quality Assurance in Medicines
Indian Pharma Compliance
Pharmaceutical Regulatory Standards
India Drug Control Measures
DCGI Pharmaceutical Oversight
Quality Assurance in Medicines
Indian Pharma Compliance

Health Secretary Calls for Stronger Regulatory Standards to Ensure Quality Medicines

Feb 25, 2025

Pharmaceutical Regulatory Standards, India Drug Control Measures, DCGI Pharmaceutical Oversight, Quality Assurance in Medicines, Indian Pharma Compliance
Pharmaceutical Regulatory Standards, India Drug Control Measures, DCGI Pharmaceutical Oversight, Quality Assurance in Medicines, Indian Pharma Compliance

Union Health Secretary Punya Salila Srivastav has emphasized the need for stronger regulatory standards to ensure that only high-quality and effective medicines circulate in India. Addressing state drug regulators at a meeting on Monday, she urged officials to strictly enforce prescription-based sales to prevent the illicit diversion of narcotic and psychotropic drugs.

Key Highlights:
Call for Stricter Drug Regulation:

  • State drug regulators must ensure that medicines are dispensed only through valid prescriptions to prevent misuse and illegal drug trafficking.

  • Strengthening regulatory oversight is essential to protect public health and curb substance abuse, aligning with the Nasha Mukt Bharat Abhiyan initiative.

Nationwide Crackdown on Illicit Drug Use and Manufacturing:

  • Srivastav commended the Central Drugs Standard Control Organisation (CDSCO) and state regulators for completing risk-based inspections of 905 drug manufacturing and testing firms.

  • These inspections resulted in 694 enforcement actions, demonstrating a firm stance against non-compliant pharmaceutical practices.

Backdrop of Opioid Crisis and Regulatory Action:

  • The meeting follows the Drugs Controller General of India (DCGI)'s ban on the production and export of tapentadol-carisoprodol drug combinations, which were linked to an opioid crisis in West Africa.

  • A Mumbai-based pharma company was found to have exported unapproved formulations of these drugs, leading to international concerns over India's pharmaceutical exports.

Statements from Officials:
Union Health Secretary, Punya Salila Srivastav:
“Regulatory standards need to be strong to ensure that only quality and effective medicines circulate in the country. State regulators must enforce prescription-based sales to prevent drug trafficking and illicit substance abuse.”The Indian government is stepping up pharmaceutical oversight, aiming to strengthen drug regulation, prevent narcotic misuse, and ensure compliance with international safety standards. More inspections and enforcement actions are expected, as authorities work to safeguard public health and India's pharmaceutical reputation globally.

Share:

Pharmaceutical Regulatory Standards
India Drug Control Measures
DCGI Pharmaceutical Oversight
Quality Assurance in Medicines
Indian Pharma Compliance
Pharmaceutical Regulatory Standards
India Drug Control Measures
DCGI Pharmaceutical Oversight
Quality Assurance in Medicines
Indian Pharma Compliance