India's apex drugs regulator has directed state governments to enforce uniform medicine standards to eliminate regional variability in regulatory compliance.
In its February directive, reviewed by Mint, the Central Drugs Standard Control Organization (CDSCO), chaired by the Drugs Controller General of India, Rajeev Singh Raghuvanshi, wrote that concerns have been raised regarding inconsistencies in the enforcement of drug standards across the country, low conviction rates in cases of drug adulteration, and the need for stringent scrutiny of adulteration in imported pharmaceutical products.
"All states are advised to take proactive measures to effectively address the issues. You are also requested to strengthen the necessary infrastructure, including the provision of adequate manpower under the State Health Regulatory Excellence Index (SHRESTH),” the letter said.
The development assumes significance for India’s $50 billion pharmaceutical market, which is facing a quality crisis after Indian-manufactured cough syrups were linked to over 140 deaths globally, including in Gambia, Uzbekistan, and Cameroon, due to ethylene glycol poisoning.
Mint's emailed queries to the health ministry spokesperson and the DCGI office on 15 April remained unanswered. While Mint couldn't reach Gopchade by phone, queries sent to his WhatsApp did not elicit a response.
A welcome move
Hari Kiran Chereddi, managing director and chief executive, HRV Pharma, said Indian pharma companies supply medicines to more than 200 countries. Global buyers do not distinguish between state jurisdictions vs central jurisdictions; they just see "Made in India”.
“A uniform enforcement framework protects that reputation by raising the floor of compliance, not just the ceiling. However, making it measurable through a common framework like SHRESTH is absolutely necessary and is very welcome. For Indian companies built on regulatory IP, this directive strengthens the foundation the entire industry relies on,” Chereddi said.
Aashish Chaudhry, managing director, Aakash Healthcare Super Speciality Hospital in Delhi, said the directive is a significant and much-needed step towards strengthening India’s pharmaceutical ecosystem.
"Patient safety must remain the utmost priority in healthcare delivery. Medicine safety is a critical component of this commitment, as it directly impacts treatment outcomes and public trust in the system,” he said.
“Uniform enforcement of medicine standards across the country will help eliminate regional variability in regulatory compliance and strengthen the integrity of the pharmaceutical supply chain. For a market as vast and complex as India’s, consistency in quality is essential," he added.
At the same time, achieving true patient safety requires more than regulation alone. It depends on having the right infrastructure, skilled and adequately trained healthcare professionals, and robust processes that together create a strong and reliable patient safety net, he said.
Long-pending issue
To be sure, Rajya Sabha member of Parliament Ajeet Madhavrao Gopchade had written to Union health secretary Punya Salila Srivastava in April 2025, highlighting critical vulnerabilities in the current pharmaceutical regulatory system, particularly inconsistencies in the enforcement of drug standards across the country.
The letter titled “Effective enforcement of medicine standards nationwide uniformly” stated that though the CDSCO regularly provides effective advisories to state drug regulators, “there has been a lack of effective implementation”.
Gopchade drew attention to the alarmingly low conviction rates in cases involving drug adulteration and the need for stringent scrutiny of adulteration in imported pharmaceutical products, while also highlighting the inadequate infrastructure and shortage of requisite manpower at the state level to facilitate inspections.
Subsequently, the DCGI chaired a meeting in late 2025 to examine the matter and emphasized the uniform implementation of drug standards nationwide.