SOS FOR DRUG REGULATION The “pharmacy of the world” needs a serious revamp

Arshad Shaikh studies the recent move by the government to centralise drug regulation in India.  Despite massive gains in the exports of drugs and vaccines, we are still plagued by shoddy regulatory standards and mechanisms. A string of deaths in some countries after allegedly consuming Indian medicines has sullied India’s image as the “pharmacy of…

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Arshad Shaikh studies the recent move by the government to centralise drug regulation in India.  Despite massive gains in the exports of drugs and vaccines, we are still plagued by shoddy regulatory standards and mechanisms. A string of deaths in some countries after allegedly consuming Indian medicines has sullied India’s image as the “pharmacy of the world”. There is an acute need for course correction in sorting out our pharmaceutical industry. Hopefully, our policymakers will live up to the task.

In the “Covid era”, India earned the title of being the “pharmacy of the world.” It developed and supplied billions of vaccines that were used throughout the world against the coronavirus. Bharat Biotech and Serum Institute of India became household names and gained an international reputation. However, this hard-earned fame came under fire when some Indian drug-manufacturing companies were accused of being responsible for the deaths of 66 children in Gambia and 18 in Uzbekistan. Despite any direct conclusive evidence, it was difficult to shrug off the allegations as the cases were pointed out by the World Health Organisation (WHO) and the Uzbek Health Ministry respectively.

It was reported that in both cases, children had consumed cough syrup that contained traces of an industrial chemical called ethylene glycol, which is poisonous and not meant for human consumption.The authorities in India did revoke the export licences of the firms linked to the drugs in question, but more was needed to undo the damage caused.

The main challenge was to ensure a uniform quality of all drugs and cosmetics manufactured across the nation. It was imperative to avoid another Gambia and Uzbekistan-like disaster. This was not possible with each state having its own level of “quality assurance” and rules of enforcement. A change in legislation was inevitable.

THE CURRENT SETUP

The task of drug regulation and monitoring (pharmacovigilance) is assigned to the Central Drugs Standard Control Organisation (CDSCO) as the central drug authority of India. Its primary job is to ensure that the drugs and cosmetics manufactured in the country are safe and without any defective formulation that may be hazardous to the health of patients.

The major functions of CDSCO include regulatory control on the import of drugs, testing, approval, and licencing of new drugs along with conducting their clinical trials. The CDCSO is headed by the Drugs Controller General of India (DCGI). The DCGI is tasked with the preparation and maintenance of a national standard to which all drug-manufacturing firms and their products shall have to adhere as well as ensure uniformity in the enforcement of the Drugs and Cosmetics Act.

However, according to this Act, the Centre is only responsible for the approval of new drugs. Issues related to the regulation, manufacturing, sales, and distribution of drugs fall under the State governments. This was the gap in the system, which created challenges in the path of “zero defect” drugs and cosmetics.

Recently, the Union Ministry of Health and Family Welfare came up with a draft bill called the “Drugs, Medical Devices, and Cosmetics Bill, 2022”. It is set to replace the current Drugs and Cosmetics Act, 1940. The new law is designed to amend and consolidate the existing setup about “the import, manufacture, distribution, and sale of drugs, medical devices, and cosmetics to ensure their quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices and for matters connected therewith or incidental thereto.”

 

CHALLENGES TO PHARMACOVIGILANCE

India’s pharmaceutical industry is beset with two basic challenges. One is quality and the other is regulation. Experts point out that this emanates because of the absence of a common and interoperable labellingand identification standard.

There is a lacuna in the availability of inspection, monitoring, and testing facilities. Databases, which track and record the history of violations, are almost negligible in number. The lack of a stable pricing regime leads to sluggish growth in third-party manufacturing – a critical component for the growth of the drug industry.

Effective implementation of quality standards is in the nascent stages of growth and establishment. Due to the unstable quality environment, Indian pharma companies have attracted the highest number of American FDA (Food and Drug Administration) visits for checking and inspection. The various problems that afflict our pharmaceutical industry have been brought out in a book called The Truth Pill: The Myth of Drug Regulation in India. Its authors, Dinesh Thakur and Prashant Reddy are very vocal about their assessment of why our regulatory framework requires a complete overhaul.

Tracing the case of the death of 12 children in Jammu after drinking alleged adulterated cough syrup made by Digital Vision in Himachal Pradesh, the authors state in their book – “There is also the question of poor regulatory design. These range from the lack of regulatory transparency to the absurdly complex distribution regulatory powers in India across 38 authorities spread across each state and union territory plus the CDSCO which works under the Union Government. For example, inspection reports of pharmaceutical facilities are not made publicly available without which there is no way to assess whether drug inspectors are doing their job as required.

“On the jurisdictional issue, since each state and union territory has its drug controller who issues licenses to manufacturing facilities, there is often little information, sharing, and coordination among them. Further inter-state investigations are extremely difficult because a drug inspector working for the Maharashtra FDA lacks jurisdiction to enter and inspect Digital Vision’s facility in Himachal Pradesh unless accompanied by a drug inspector from the HPDCA. The HPDCA, however, has its reasons to not permit such inspections, the most important of which is the fact that the state government wants to continue pitching the state as a hub for pharmaceutical manufacturing. Together, these various flaws cause catastrophes like the deaths of these 11 young children.”

 

CENTRALISED REGULATION

Finally, the government is moving towards a common standard of drug regulation and a central database. The draft of the “Drugs, Medical Devices, and Cosmetics Bill, 2022” has a provision to regulate medical devices separately as well as begin the regulation of e-pharmacies. The new law imposes fines and imprisonment for injuries and deaths during clinical trials. The penalties range from imprisonment for one year to 10 years and fines up to Rs 15 lakhs.

The Bill also brings AYUSH products namely Ayurveda, Yoga, Unani, Siddha, and Homeopathy under its fold. One aspect that is never taken up under any attempt to clean the system is the issue of moral regulation.

Unless the manufacturer adheres to a self-imposed ethical standard that makes one’s earnings lawful only if one gives the best for the price charged, the industry shall always be besieged with malpractices and sub-standard products. These ethical standards in society cannot be set by enhancing and tightening regulatory policies. It requires a moral transformation, which can only be brought about by correct religious beliefs and “God-consciousness”. Paying heed to the Qur’ānic advice –“Give full measure when ye measure, and weigh with a balance that is straight: that is the most fitting and the most advantageous in the final determination” (17:35), can be the first step in that direction.