The issue of substandard medicines available for sale in India came to the fore in the Rajya Sabha today by Deputy Leader of Opposition Pramod Tiwari, who called for greater awareness and better quality controls in drug production. Drawing upon reports by Drugs Controller General of India (DCGI), he sounded an alert that more than 50 medicines, including those that are life-saving, have failed quality tests, posing a serious threat to public health.

Key Highlights:
Problems Concerning Poor-Quality Medicines:

• Reports indicate that poor-quality drugs like paracetamol, blood pressure medications, cough remedies, multivitamins, and calcium supplements are being marketed on a massive scale.

• In 2022, a study found that over 15% of medicines manufactured by small pharmaceutical companies failed quality tests, with rural areas being the hardest hit.

• 12 to 25% of Indian-produced medicines may be adulterated, substandard, or counterfeit, it is estimated.

Regulatory Reforms and Industry Impact:

• Amendments to the Public Health Bill in 2023 made compounding of offenses under 27 DMSQ possible, and now manufacturers can settle by paying fines rather than facing legal action for producing substandard medicines.

• Tiwari argued that this provision would encourage the production of poor-quality drugs rather than improving standards.

Rise in Substandard Medicines in Government Hospitals:

• 38% of substandard medicines are being prescribed in government hospitals, and there is an issue of patient safety.

• Since 2015, the condition of spurious and substandard medicines has apparently worsened, and there is a need for the government to step in on an urgent basis.

Quotes of Leaders/Officials:
Pramod Tiwari, Deputy Leader of Opposition in Rajya Sabha:
"More than 50 medicines found in the country are substandard and health hazardous. We must ensure stringent quality checks and raise awareness so that more harm does not occur."

Parliamentarians' anxiety is reflective of the well-overdue imperative for increased regulation in India's pharma market. As mounting cases of spurious drugs enter the books, policymakers are nudged towards strictening quality laws, enforcing strengthened drug testing centres, and ending the prevalence of counterfeit or low-quality drugs. The tug between the merits and demerits of penalties and stronger punishment continues, but commentators agree that the interest of the public has to come first.