The pharmaceutical sector in India has witnessed exponential growth since the economic liberalization reforms in the 1990s. The nation went from being a mass importer of pharmaceutical drugs and medicines to one of the world’s leading suppliers. India emerged as the largest supplier of vaccines by volume in the world and the industry is currently valued at $50 billion expected only to increase in the coming years. The expansion not only promises India substantial economic benefits but also suggests the possibility of greater pharmaceutical sector innovation. To reach the growth potential, there are some acknowledged challenges and bottlenecks that must be overcome, just as with any industry pursuing rapid growth and capturing the global market. The pharmaceutical sector in India needs to pay attention to quality and regulatory issues. The existing regulatory framework consists of the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, and other State Drug Control agencies which are, ironically, obstacles in the process of quality control and industrial safeguards due to lack of statutory backing, transparency and a central database or body of complete authority on the matter. The lack of regulations has resulted in the loss of life and bodily harm, most recently seen in Gambia and Jammu. The paper also explores the issue of establishing a direct link between the health issues caused by defective drugs and the drugs themselves impedes the accountability of the companies in question and suggests steps to streamline the pharmaceutical sector in India.
To regulate or not regulate?
The CDSCO is the primary drug control regulator in the pharma market. It comes under the ambit of the Directorate General of Health Services (DGHS). The Drugs Controller General of India (DCGI), who oversees the CDSCO, is answerable to the DGHS, Health Secretary, and Health Minister.
In actuality, the Health Ministry's drug regulation division, which is run by a Joint Secretary-level officer but lacks technical expertise and depends on the CDSCO, has more authority.
In addition to the central system’s mismatched hierarchy, 38 state and UT regulatory agencies exacerbate the issue by distributing the power unevenly without transparency. The lack of a centralized system to record inspection status, violations, and prior history of a firm makes it impossible for interstate communications regarding the same. E.g., Even if a food and drug inspector from Tamil Nadu knows about a factory producing subpar-quality drugs in Maharashtra, they do not have the jurisdiction to conduct a raid.
The red-tapism and gross oversights involved in the process of drug regulation are Kafkaesque and have resulted in the loss of life both nationally and internationally.
COLDBEST: Brake Fluid or Cough Syrup?
Just before the onset of the Covid-19 pandemic, 21 children, mostly from Ramnagar in Jammu, were hospitalized for an unknown condition. The symptoms initially started with a cold which was common for the region and season but progressed into renal failure. A team at the Post-Graduate Medical Institute of Research (PGMIR) tested COLDBEST, a cough syrup manufactured in Himachal Pradesh that the patients had consumed before admission and found Diethylene Glycol (DEG) in the medicine. This compound is used in antifreeze, brake fluids, cosmetics, lubricants, and other commercially available products and can cause kidney toxicity if ingested. Unfortunately, by the time the cause of the symptoms was identified, 11 of the infants afflicted with it had passed away.
In the case of Digital Vision V. The State of Himachal Pradesh, the Himachal Pradesh Drug Control Administration alleged that the manufacturer of COLDBEST – Digital Vision did not possess adequate facilities to test its product for DEG contamination and falsified its quality control reports. Although the firm refuted these claims, it raises the question: How did the HPDCA miss such blatant violations of the Goods Manufacturing Practices7 during prior inspections?
Even though there was understandable public outrage and lawsuits filed by the parents of the victims, the case got tied up in litigation and soon, fell into obscurity due to bureaucratic process. Until August 2020, when the same firm was found manufacturing the same cough syrup containing DEG under the name of COFSET AT! The HPDCA then suspended the company's manufacturing license and the regions where the drug was distributed, were asked to stop its sale with immediate effect but alas, the cough syrup had already claimed the life of a two-year-old child by then.
The above case is a perfect example of the sheer negligence that has found a place right in the heart of India’s pharmaceutical regulations. The fact that the same company was allowed to peddle a product that killed 11 people for the second time is an act of gross incompetence on the part of DCGI and the HPDCA. Beyond the lack of regulatory control, there also lies the problem of quantifying the consequences of Not Standard Quality drugs; the evidence is circumstantial at times, and only a detailed report of previous inspections and tests can link the crime to the source.
What needs to be done?
The solution to the issue of the pharma regulations in India, or the lack thereof is two-pronged. Firstly, an Act of Parliament must be passed to make the CDSCO a statutory body and bring all the state and UT agencies under its umbrella. Becoming a statutory body will ensure legitimacy and give the organization the power to enact legislation and rules to standardize the practice of drug manufacturing in India. Secondly, a central database containing the profiles of every entity possessing a drug manufacturing license must be created and their quality control reports, inspections conducted by agencies, past offenses, pending litigation against them, etc must be filed in the same for ease of access and centralization. Interstate and State-Central communication regarding potential violations must be streamlined and routine checks need to be conducted to ensure the state bodies are functioning effectively. Pharmaceutical regulations are vital to public health; thus, we must make sure that only standard-quality medications are made and sold.