Recent cases of inferior and tainted pharmaceuticals in India have prompted worries about the pharmaceutical industry’s quality and regulatory control. While India takes pleasure in being the world’s largest maker of generic medications, it is critical that it address recurrent quality concerns in order to maintain its reputation and protect public health.
Tragedy highlights quality concerns
- Digital Vision Contamination: In January 2020, 12 children in Jammu died after taking tainted Digital Vision medicine that contained diethylene glycol. Despite previous red flags from drug laboratories, another incidence occurred six months later, resulting in the death of a two-year-old who had consumed the same manufacturer’s Cofset cough syrup.
- Nycup Syrup: In March 2021, it was discovered that Nycup syrup contained reduced levels of the active component, raising concerns regarding quality control. However, the manufacturer’s effective response was hampered by restricted regulatory action.
An outline of India’s drug regulation system
- CDSCO (Central Drugs Standard Control Organisation): The CDSCO, which reports to the Ministry of Health and Family Welfare, is India’s major regulatory authority in charge of the approval, regulation, and control of pharmaceutical products. It is responsible for issuing licences, conducting inspections, and overseeing drug manufacturing, importation, and distribution.
- The Drug Controller General of India (DCGI) is the head of the CDSCO and is in charge of drug regulation in India. The DCGI is in charge of new drug approval, clinical studies, and the control of imported medications.
- The National Pharmaceutical Pricing Authority (NPPA) regulates the prices of critical pharmaceuticals in India in order to ensure affordability and accessibility. It monitors and manages the costs of scheduled medicines and establishes pricing recommendations for pharmaceutical items.
- PvPI (Pharmacovigilance Programme of India): PvPI is a nationwide programme that monitors and reports adverse drug reactions (ADRs) to safeguard the safety of medications. It encourages healthcare professionals and the general public to report any suspected adverse drug reactions (ADRs) to a centralised database for study and evaluation.
- Protection of Intellectual Property Rights (IPR): The regulatory framework includes safeguards to safeguard intellectual property rights connected to pharmaceutical inventions and innovations. This fosters the launch of new pharmaceuticals and promotes industry research and development.
- Manufacturing Standards: The CDSCO ensures that drug manufacturers in India follow good manufacturing practises (GMP) to ensure that pharmaceuticals are of high quality and safe for usage.
- Clinical Trials: In India, the CDSCO oversees clinical trials to ensure that they are performed ethically and with participant safety in mind. The CDSCO requires clinical trials to adhere to the International Conference on Harmonisation (ICH) guidelines.
Challenges in the Indian pharmaceutical industry
- Fragmented Regulatory Structure: With roughly 36 drug regulators in India, regulatory oversight coordination and consistency become difficult. A consolidated and centralised regulatory body can reduce the possibility of regulatory capture while also ensuring consistency across jurisdictions.
- Persistent Quality concerns: Despite being the world’s largest manufacturer of generic medications, India has experienced quality concerns. Recent inspections revealed that 48 medications did not fulfil quality standards, putting patient safety at risk.
- Global Reputation at Risk: Global regulators, such as the US FDA, have seen compliance difficulties in Indian pharmaceutical facilities, potentially ruining India’s image as a quality medication manufacturing country.
- Limited Regulatory Action: In some instances, regulatory action has been limited or challenging to implement due to various reasons, making it difficult to effectively address quality issues and hold manufacturers accountable.
- Inadequate Transparency and Accountability: A lack of transparency in the drug regulatory environment undermines public trust. The lack of public availability of drug application evaluations, inspection data, and past infractions makes evaluating manufacturers’ compliance and track record difficult.
- Inspection and Enforcement Capacity: The sheer number of pharmaceutical manufacturing units in India, coupled with the large-scale inspection load, puts strain on the inspection teams under state drug controllers.
Way ahead
- Regulatory Reforms: Amend the pharmaceutical and Cosmetics Act (1940) to create a centralised pharmaceutical database for effective monitoring. To reduce state-level patronage and influence networks, combine regional regulators into a single regulatory agency. Implement uniform standards across all states.
- Enhanced Transparency and Reporting: Create a public database of past violations, inspection records, and failure histories, as well as publish complete reports on drug testing laboratory findings. Introduce a national drug recall law that empowers victims and penalises companies that export counterfeit pharmaceuticals.
- Increasing the effectiveness of the Central Drugs Standard Control Organisation (CDSCO): Establish a Central Drugs Authority as an independent agency with statutory underpinning to ensure effective regulation and enforcement.
- Accountability in the Pharmaceutical sector: Moving beyond generic manufacturing, the pharmaceutical sector should focus on producing high-quality generic and innovative pharmaceuticals. Adopt zero-defect principles and put public health first.
@the end
To address the issues confronting India’s pharmaceutical business, fundamental changes such as regulatory consolidation, openness, intensified inspections, and industry responsibility are required. India’s pharmaceutical industry can restore its status as a global leader in drug manufacture by prioritising patient safety and assuring the delivery of quality medications.
Source: https://ficci.in/spdocument/23240/FICCI-Report_Regulatory-Reforms-for-Pharma-Sector.pdf