In India, pharma is regulated by the Drugs and Cosmetics Act of 1940, and the Rules of 1945 create a stringent regulatory framework. This framework oversees the import, manufacture, distribution, and sale of pharmaceutical goods. The state drug regulatory bodies, with their authority to regulate the grant of licenses, production, marketing, and distribution of medicines, are instrumental. However, it is the central drug regulatory body that truly inspires confidence. Its pivotal role in approving new drugs, conducting clinical trials, setting standards for drugs, and ensuring the quality of imported medicines is the backbone of the regulatory process, ensuring the safety and quality of pharmaceutical drugs in India (As per the Drugs and Cosmetics Act, 1940 as amended up to 2016). The quality, effectiveness, and safety of pharmaceutical products are paramount from a healthcare perspective, both in a country or region. However, various online articles do reflect concerns over the quality of drugs in India. The article demonstrates an overview of the same.
Indian Pharmacopoeia
The Indian Pharmacopoeia (I.P.), published by the Indian Pharmacopoeia Commission (IPC), is the official book of drug standards in India (Indian Pharmacopoeia, 2022). The standards prescribed in the I.P. are authoritative and are enforced by the regulatory authorities for the quality control of medicines in India. The IPC fulfils its aim by creating and publishing I.P. standards for drugs and aiding in their implementation through a robust regulatory framework within the country. The I.P. comprises a comprehensive collection of approved procedures for drug analysis, along with their specifications, for drugs imported, manufactured, stocked, exhibited for sale, or distributed within India (Drugs and Cosmetics Act, 1940). I.P. so far is recognised as the standard book in 5 countries.
How many times the Act has been amended?
The Drugs and Cosmetics Act of 1940 and the Rules made thereunder in 1945 are the principal laws governing drug control in India. The Act ensures that drugs and cosmetics sold in India are safe, effective, and conform to state quality standards.
The focus on the quality of drugs is reflected in several provisions of the Act and the corresponding Rules:
Standards of Quality: According to the Act, a drug is deemed of standard quality if it complies with the standards set by the Act, the Rules, and the Pharmacopoeias listed in the Second Schedule of the Act.
Manufacturing and Sale: The Act regulates the manufacture and sale of drugs by requiring manufacturers to obtain licenses. These licenses mandate adherence to good manufacturing practices (GMP) and labelling requirements, ensuring that the medicines produced are of the prescribed quality.
Testing: The Act establishes drug testing facilities and procedures. All drugs must pass quality tests before being made available to the public. The Central Drugs Standard Control Organization (CDSCO) and State Drug Control Laboratories play a crucial role in this process as critical players in drug sample testing.
Inspections and Monitoring: The Act empowers inspectors to take samples and inspect manufacturing facilities to ensure compliance with the quality norms. Non-compliance can lead to the suspension or cancellation of manufacturing licenses.
Potent and Hazardous Substances: Special provisions are made for potent and hazardous substances, where stricter quality checks are mandated.
Penalties for Non-Compliance: The Act stipulates penalties for the manufacturing and sale of drugs that are not of standard quality, are misbranded, adulterated, or spurious. Penalties can include fines and imprisonment.
The Drugs and Cosmetics Act of 1940 has undergone several amendments; online information indicates that it has been amended about six times since its enactment to address various aspects of drug and cosmetic regulation in India. These amendments are a testament to the continuous efforts to align the legislation with the evolving medical and pharmaceutical industry, emerging health challenges, and international best practices.
It was amended in 1955, 1960,1972, and 2008, but some of the significant amendments include:
The Drugs and Cosmetics (Amendment) Act of 1964 introduced comprehensive provisions for controlled clinical trials.
The Drugs and Cosmetics (Amendment) Act of 1982 made significant changes to ensure excellent drug safety and efficacy.
The Drugs (Control) Amendment Act of 1995 aimed to strengthen drug control provisions.
More recently, various proposals have been made for further amendments to the Act to streamline the regulatory mechanisms for drugs and cosmetics. The government has also proposed a draft bill to replace the existing Act with a new legislation that aims to be more comprehensive and relevant to current needs.
It is essential to regularly check for the latest updates, as the legal framework governing drugs and cosmetics is subject to change.
Quality of Indian Drugs
The concern over the quality of drugs is a very challenging issue. The red flags for national generic drug manufacturing were highlighted in an article (Ruth et al. 5, 2023, Japan Times, just how dangerous are India’s generic drugs? Very. Website). India is the largest producer of the generic drug.
India’s regulatory oversight needs to be improved, and it still relies on outdated analogue practices instead of modern digital ones. An Indian drug manufacturer, Intas, produced cancer drugs for the United States at their plant. However, six months after the drugs were imported, the FDA deemed them adulterated and stopped imports from the plant. This contributed to a severe shortage of lifesaving cancer drugs in the United States, which, according to U.S. physicians, could result in thousands of deaths. To address the crisis, the U.S. government has sought help from China despite its efforts to reduce its dependence on the country. As a result, Qilu Pharmaceutical, a Chinese company, has been asked to help address the shortfall. (Sayan Chakraborty And Cissy Zhou March 22, 2024, Nikkei Asia, India pharma quality lapses force the U.S. to look to China for lifesaving drugs, Website).
At least 18 children died in Samarkand after allegedly consuming the Doc-1 Max cough syrup manufactured by Indian pharmaceutical company Marion Biotech. Similarly, cough syrups produced by Indian drugmaker Maiden Pharmaceuticals have been associated with the deaths of 66 children and acute kidney injuries in Gambia. The new regulation is set to take effect from the beginning of June. (Murali Krishnan, June 2, 2023 D.W. Is India doing enough to clean up its pharma industry? Website)
Conclusion
Chicago Tylenol Murder revolutionized the pharma industry in the USA. India has made it mandatory for cough syrup manufacturers to provide product samples for testing before exporting. The Indian pharmaceutical industry has around 10,500 companies, and the exports of drugs have more than doubled in the last decade (as of 2023). Recently, proposals have been made to amend the Act further to streamline the regulatory mechanisms for drugs and cosmetics. The government has also proposed a draft bill to replace the existing Act with more comprehensive and relevant legislation that meets the current needs. However, much must be done to inspire consumers’ confidence and create a world standing.
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