Context
- The Union Health Ministry in India is considering the formulation of common standards for drug regulators across the country.
- This is aimed at improving the drug regulation mechanism in India by ensuring consistent implementation of standards and facilitating better monitoring of drug safety.
- It is probably a move likely triggered by recent deaths globally that were linked to the consumption of drugs manufactured in India.
Common Drugs Standards: Key features
- Unified national portal: The portal is intended to bring together various drug regulatory functions and processes, currently managed by different government agencies, onto a single platform.
- Centralized database: It will be used for information related to drugs, manufacturers, and regulatory authorities, as well as a single-window clearance system for drug approvals.
- Drug safety monitoring: The portal will also include modules for monitoring drug safety and pharmacovigilance, and for facilitating online submission of applications for various regulatory processes such as drug approval, clinical trials, and licensing.
Institutions involved
- The portal is being developed by the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for pharmaceuticals and medical devices in India.
- The CDSCO is working with other government agencies, including the Ministry of Health and Family Welfare, to ensure that the portal is integrated with existing regulatory frameworks and systems.
Need for Common Standards and Regulations
- Huge market potential: India ranks 3rd worldwide for production by volume and 14th by value in the pharma sector.
- Multiple regulators: The current system is fragmented with 38 drug regulators, each with its own database.
- Multiple standards: A common set of standards and regulations accepted by both central and state authorities is being worked upon.
- Easy evaluation: The move could help drug regulators across India know the credentials of all pharmaceutical companies and drugs at the click of a mouse.
Benefits offered
- Once operational, the portal is expected to benefit various stakeholders in the pharmaceutical industry, including drug manufacturers, regulatory authorities, healthcare professionals, and patients.
- It is expected to-
- Improve the efficiency of regulatory processes
- Reduce delays in drug approvals and
- Enhance drug safety monitoring in India
Why such a move?
Ans. Recent Cases of Deaths Linked to Drugs Exported from India
- In the past six months, there have been at least three cases of deaths reported globally that are linked to drugs exported from India.
- Global Pharma Healthcare Private Limited recalled a batch of eye drops from the US market after they were contaminated with a drug-resistant bacteria linked to permanent vision loss and resulted in one death from a bloodstream infection.
- An inquiry was launched against Marion Biotech after deaths of 18 children in Uzbekistan were linked to the firm’s consumption of syrup.
- WHO issued a medical product alert over four cough syrups manufactured and exported by Maiden Pharma. At least 70 children died in The Gambia likely after consuming the said cough syrups.
Present Drug Regulation Mechanism in India
In India, drug regulation is overseen by the Central Drugs Standard Control Organization (CDSCO), a national regulatory body for pharmaceuticals and medical devices. The CDSCO is responsible for regulating the import, manufacture, distribution, and sale of drugs in India.
The following is an overview of the drug regulation mechanism in India:
- Drug Approval Process: Before a drug can be marketed in India, it must undergo a thorough approval process by the CDSCO. This includes pre-clinical studies, clinical trials, and submission of a New Drug Application (NDA) or a Marketing Authorization Application (MAA).
- Drug Pricing: The National Pharmaceutical Pricing Authority (NPPA) is responsible for regulating the prices of drugs in India. The NPPA regulates the prices of essential medicines and monitors the prices of non-essential medicines to ensure they are not unreasonably high.
- Drug Safety Monitoring: The Pharmacovigilance Programme of India (PvPI) is responsible for monitoring the safety of drugs in India. The program collects and analyzes data on adverse drug reactions (ADRs) to identify potential safety concerns and take appropriate action.
- Manufacturing Standards: The CDSCO ensures that drug manufacturers in India adhere to good manufacturing practices (GMP) to ensure that drugs are produced under quality standards and are safe for use.
- Clinical Trials: The CDSCO regulates clinical trials in India to ensure that they are conducted ethically and with the safety of participants in mind. The CDSCO requires that clinical trials follow the guidelines of the International Conference on Harmonization (ICH).
Issues with the above system
- Slow Approval Process: The drug approval process in India is often criticized for being slow and cumbersome, leading to delays in the availability of new drugs to patients.
- Inadequate Drug Safety Monitoring: Despite the existence of the PvPI, there are concerns that the monitoring of drug safety is not adequate, leading to underreporting of adverse drug reactions (ADRs) and delayed response to safety concerns.
- Lack of Transparency: There have been concerns over the lack of transparency in the drug approval process, with accusations of corruption and conflicts of interest among regulatory officials and drug manufacturers.
- Inconsistent Implementation of Standards: While India has established good manufacturing practices (GMP) standards for drug manufacturing, there are concerns that these standards are not consistently implemented, leading to quality issues with some drugs.
- Limited Access to Affordable Drugs: While the NPPA regulates the prices of essential medicines, there are concerns that the prices of non-essential drugs are often unaffordable for the average Indian patient.
Challenges in implementation of a common standard
- Healthcare being state list subject: India is a federal state and health is a state subject, which may make it difficult to implement the idea.
- States hegemony: A central database will be difficult to maintain if states do not share accurate data in a timely manner.
Way forward
- Streamline the Approval Process: The government should consider simplifying and expediting the drug approval process while maintaining safety standards. This could involve the use of modern technologies and innovative regulatory pathways, such as accelerated approval and conditional approval, to speed up the approval process for drugs that meet certain criteria.
- Strengthen Drug Safety Monitoring: The government should allocate more resources to PvPI to enhance its capacity for monitoring drug safety. This could include increasing the number of trained personnel, improving data collection and analysis systems, and implementing a more robust system for reporting and responding to adverse drug reactions (ADRs).
- Increase Transparency: The government should take steps to increase transparency in the drug approval process, such as making the regulatory framework and decision-making processes more open and accessible to the public.
- Improve Implementation of Standards: The government should work with drug manufacturers to improve the implementation of good manufacturing practices (GMP) standards, through increased regulatory inspections, penalties for non-compliance, and capacity-building programs for manufacturers.
- Ensure Access to Safe and Affordable Drugs: The government should explore ways to make non-essential drugs more affordable to the average Indian patient, such as by negotiating better prices with drug manufacturers or promoting generic drug usage through public awareness campaigns.
Conclusion
- Overall, the development of a unified national portal for drug regulatory functions is a significant step towards modernizing the drug regulation mechanism in India and bringing it in line with international standards.
- It is expected to facilitate the growth of the Indian pharmaceutical industry and contribute to the overall health and well-being of the Indian population.
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