Govt plans common drugs standards for all state regulators

The move could instil order and unify a fragmented system spanning 38 drug regulators, each with its own database

The Union health ministry is considering formulating common standards for drug regulators at the Centre and the states and maintaining a central database to better regulate the manufacturing, sale, and distribution of drugs, according to people familiar with the matter -- a move likely triggered by recent deaths globally that were linked to consumption of drugs manufactured in India.

In the past six months, there have been at least three cases of deaths reported globally that are linked to drugs exported from India.

“A common set of standards and regulations accepted by both central and state authorities (is being worked upon). Steps are being taken to ensure harmonization of regulatory requirements, processes, and procedures as well as databases across all states to ensure consistency in the evaluation and approval of drugs,” said a senior health ministry official, requesting anonymity.

The move could instil order and unify a fragmented system spanning 38 drug regulators, each with its own database. If a state drug regulator identifies violations by a drug company in the state, chances are, under the current system, knowledge of the same will not be shared with drug regulators in other centres or with the federal drugs regulator, the Central Drugs Standard Control Organisation (CDSCO).

Once adopted and implemented, the new regime could help drug regulators across India know the credentials of all pharmaceutical companies and drugs at the click of a mouse.

“India follows a system, where both Central and the state governments have important roles to play in issuing manufacturing licenses and regulating the drug sector. There is need for a common set of standards and regulations. This requires a significant collaboration from all stakeholders involved,” added the official.

“India does not have a consolidated public database that records the transgressions of each company licensed under the Drugs And Cosmetics Act,” Dinesh S Thakur and Prashant Reddy, authors of The Truth Pill wrote in an Op-Ed in Hindustan Times last year. “We use the word “consolidated” because India has 38 drug regulators today — one for each state and Union Territory, plus the national regulator, Central Drug Standard Control Organisation (CDSCO). Each controller has its own network of laboratories to test drugs drawn from the market under its jurisdiction by its drug inspectors. Between the Union and the states, India has 37 drug-testing laboratories, yet laboratories of only three states — Gujarat, Maharashtra and Kerala — make their results available in a consolidated database ,” they added.

In the past six months, there have been at least three cases of deaths reported globally that are linked to drugs exported from India.

Last month, a Chennai-based pharmaceutical company, Global Pharma Healthcare Private Limited, recalled a batch of eye drops from the US market after the US FDA said they were contaminated with a drug-resistant bacteria linked to permanent vision loss and had resulted in one death from a bloodstream infection.

In December, last year, India launched an inquiry against the Noida based drugs manufacturer, Marion Biotech, after deaths of 18 children in Uzbekistan were linked to consumption of a syrup manufactured by the firm.

In a briefing in October, last year, WHO (World Health Organisation) issued a medical product alert over four cough syrups manufactured and exported by Haryana-based Maiden Pharma. At least 70 children died in The Gambia likely after consuming the said cough syrups.

The health ministry, last month, conducted a two day “Chintan Shivir” (brainstorming session) with a focus on drugs quality, regulation, and enforcement, and the harmonisation of regulations, and the creation of a common database appears to be one outcome.

“A need was felt to hold a Chintan Shivir on this issue keeping in view the strong position of India as safe, affordable, and reliable supplier of quality medicines to the world which was unequivocally appreciated by all countries during the Covid pandemic. There is a need to ensure that all manufacturing in the Country, whether it is by MSMEs or by India based big drugs manufacturers, complies with Good Manufacturing Practices (GMP),” said another health ministry official, requesting anonymity.

The official added that discussions at the session helped prepare the roadmap for a future ready regulatory system and also helped identify the concerns of the pharma industry and other stakeholders.

A section of experts, however, felt that the idea might be difficult to implement.

“It is an excellent idea, but constitutionally India is a federal state and health a state subject; therefore an idea like this would need everyone to come on board willingly. A central database will be difficult to maintain if states do not share accurate data in a timely manner. It will be a long drawn process wherein enough awareness would need to be generated among states for their active participation. That said, there is no harm in trying as it will be for the betterment of the regulatory system,” said Subhash C Mandal, regulatory affairs division, Indian Pharmaceutical Association.