Drug regulatory reforms for improving quality

The Indian pharmaceutical sector has played a pivotal role in enhancing global health outcomes, as well as increasing global availability of cost-effective medication, thus garnering India the moniker of the “pharmacy of the world”. Multiple initiatives have been taken in the recent past for strengthening the drug regulatory system to augment the quality of the drugs being manufactured in the country for the domestic market as well as for exports.

Keeping better quality management in mind, the Ministry of Health and Family Welfare has framed the draft Drugs, Medical Devices and Cosmetics Bill, 2023, to make it more relevant for the drugs, cosmetics and medical devices domain. The new Bill, in the final stages of approval, clarifies multiple definitions required in pharmaceutical, cosmetics and medical devices sectors, which will bring clarity in multiple processes and help in better execution of regulations. It also proposes to have a separate vertical with regulators having domain-linked education and exp­ertise for regulating medical devices.

The current Schedule M of the Drugs and Cosmetics Act, 1940, is being revised and upgraded to make it more comprehensive and bring it on a par with the World Health Organization’s good manufacturing practices (WHO-GMP) guidelines. It will help the Indian pharmaceutical industry to gain better recognition at the global platform because of its similarity to global GMPs. The notification for the same is ex­pected shortly, and its sub­sequent implem­entation will bring in in­cr­e­ased qua­lity monitoring and involvement of stakehold­ers. Curre­ntly, sensitisation prog­rammes are being conducted in different parts of the country to highlight the new provisions in the revi­s­ed Schedule M and to orient the industry, especially the pharma MSME (micro, small and medium enterprises) sector.

For strengthening the quality management systems and enforcing strict compliance to Drugs and Cosmetics Act and Rules (D&C Act & Rules), a risk-based ins­pection (RBI) was initiated in Dec­em­ber 2022 and is currently being pursued aggressively throughout the country. A total of 236 inspections have been carried out, which also includes 40 public testing labs. In case of non-compliances, various measures like show cause notice (157), cancellation/suspension of licence (26), stop production order (50), warning letter (32), stop testing order (2) etc. have been initiated.

The Directorate General of Foreign Trade (DGFT), in consultation with the health ministry, issued a notification on May 26, 2023, for testing of cough syrup batches in designated labs before being exported from India. So far, 1,492 batches have been tested and 399 batches are being analysed. Out of the 1,492 tested, 80 batches from 30 manufacturers have been found to be not of standard quality. These 30 companies have been made part of the RBI list, are getting audited, and commensurate action is being taken against them. None of these batches have failed in DEG/EG (diethylene glycol/ ethylene glycol) content, which was a concern in the recent past.

In order to increase the regu­lat­ory/technical capacity of regulators, a monthly residential training programme is being conducted by the Central Drugs Stan­dard Control Organisation (CDSCO). One of the gaps identified to be address­ed is improvement in alignment between the central and state regulators and among different state re­gulators. Monthly meetings have been initiated with all the states and CDSCO to discuss the ongoing issues related to regulatory processes and their interpretation according to the Act and Rules. In addition, weekly meetings are being conducted with stakeholder states for discussing RBI related issues to expedite the actions based on CDSCO’s post-audit recommendation.

To bring better alignment among regulators, CDSCO has prepared three standard operating procedures (SoPs) for uniform interpretation and execution of the Act and Rules. These are SoPs on sampling from market, on actions to be taken based on RBI observations, and on req­ui­rement of documents and data for various licences issued by central and state regulators. These meetings and discussions have helped improve the coordination among different regulatory stakeholders.

As India adopts digital technologies in every sphere, the pharma sector is also seeing a rise in digital interventions for capacity building. Currently, 70 per cent of the licensing and regulatory processes are being done digitally on the Sugam portal, with the aim to make it 100 per cent during this financial year. Some of the applications like blood bank licensing, post-approval changes in vaccines and rDNA products are in the testing phase and would be operational in the next one month. All CDSCO labs are online now and the sample movements at different Sugam labs can be viewed centrally. Deve­lopment of the system for online submis­sion of legal samples by drug inspectors has been completed and is now being tested.

The Online National Drug Licensing System for states is a common platform developed for submission and processing of applications for grant of licence for drugs and cosmetics for all the state/Union Territory drugs controlling authorities. Eleven states are already on-board, whereas Jharkhand and Himachal Pradesh are in the last phase of on-boarding. Discussion with other states is also ongoing. Each division in CDSCO is being monitored using digital data from the Sugam portal by the Drugs Controller Ge­n­eral of India on pendency, and accountability is being established.

A strong drug regulation system is essential for India, as it not only supplies quality drugs to its own population but is responsible for meeting 20 per cent of the global demand for generic drugs. The recent reforms in drug regulation will only help bolster India’s position as a trustworthy manufacturer of quality drugs and as a nation committed to imp­ro­ving health outcomes worldwide.

The writer is secretary (health), Ministry of Health and Family Welfare, Government of India. Views expressed are personal