The Drugs and Cosmetics Act 1940 is a legislation that regulates the manufacture, sale, import, and export of drugs and cosmetics in India. Section 27 D of the Act was amended in 2022 to decriminalize the manufacture and sale of drugs that do not meet the standards.
This means that people will no longer be prosecuted for manufacturing or selling drugs that are substandard, ineffective, or harmful.
This amendment exempts pharmaceutical companies from facing criminal cases for manufacturing low-quality medicines. The amendment replaces imprisonment of up to two years with a mere fine for the owners and managers of pharmaceutical companies.
This amendment has faced strong opposition from doctors, healthcare workers, and other professionals due to the potential risks to patients' health and lives, considering the production of substandard medicines.
The government clarified that Sections 27(a), (b), and (c) of the Drugs and Cosmetics Act, 1940 have not been amended. Cases involving counterfeit and spurious drugs will still face legal action, including imprisonment and fines.
The debate revolves around what defines substandard quality or "Not of Standard Quality" (NSQ) medicines. The government and the pharmaceutical lobby argue that NSQ medicines only have slightly lower quality than legally mandated minimum standards and don't pose significant health risks.
However, there are concerns that NSQ medicines can still harm patients' health and well-being, and this amendment lets pharmaceutical companies off the hook.
Instances of substandard and adulterated medicines have been reported in India recently, highlighting the need for stringent quality control and regulations.
The government's move to ease penalties for pharmaceutical companies has been criticized for prioritizing financial interests over public health.
There have been cases where substandard drugs have caused harm or even death, highlighting the dire need for quality control and accountability.
The government's approach is seen as prioritizing profit over public health, and there's a call for strict monitoring and regulations on the pharmaceutical industry.
The focus should be on assessing the impact of substandard medicines on public health and considering alternate solutions rather than giving pharmaceutical companies immunity from legal actions.
Critics argue that the government's policies and amendments favor corporate interests over the well-being of the citizens, highlighting a broader pattern of anti-people policies.