Is uniform implementation of drug approval system a possibility in India?

Stakeholders in the pharmaceutical industry want the Union government to form a clear framework to ensure uniform implementation of the drug approval system. This follows alleged adulteration in drugs manufactured in India being blamed for deaths abroad.

However, the Centre has said that the state drug control authorities primarily regulate the manufacture, sale and distribution of drugs in the country, while the central government, through the Central Drugs Standard Control Organisation (CDSCO), exercises control over drugs imported into the country.

“As per information received from CDSCO, the number of drug manufacturing units in the country is 10,706 as of December 31. The Department of Pharmaceuticals does not maintain the details of company-wise quantum of drugs manufactured,” said Bhagwant Khuba, MoS, Ministry of Chemicals and Fertilisers, when asked whether the government has any mechanism to regulate and monitor the manufacturing and marketing of drugs by pharma companies.

Last week, Krishna Ella, the chairman of Bharat Biotech, said all the state drug regulatory bodies should be merged into the CDSCO to ensure "one quality, one standard".

Responding to a question by Moneycontrol on a growing list of foreign countries flagging the adulteration of Indian drugs, Ella said that a single regulatory framework in India will be helpful.

Also read: Merge state, central drug regulators for better standards: Bharat Biotech chairman

Ella’s views were echoed by GN Singh, former Drugs Controller General of India (DCGI), who said he had proposed a uniform drug approval mechanism during his tenure but it wasn’t taken ahead due to ‘unknown reasons’.

“During my tenure as DCGI, I had initiated a proposal for bringing uniformity in the implementation of drug rules. It is very important for quality assurance that all the state and central regulators should be on one page,” Singh said.

Singh added that political will was needed to strengthen the state-level regulatory apparatus with complementary roles of the Centre and the states, while at the same time ensuring uniform and effective implementation.

Vivek Sehgal, Director General, Organisation of Pharmaceutical Producers of India (OPPI), representing research-based pharmaceutical companies, said his organisation was in favour of creating a simplified single-window drug approval and regulatory system for the pharmaceutical industry in India.

“We hope that this will ensure transparency and eliminate the potential for falsified drugs to circulate in the system. We remain committed to collaborate with the government authorities in case this is implemented. At OPPI, our priority is solving the healthcare challenges for India, keeping the patient at the core of all our decisions,” Sehgal added.

Disconnection issues

Singh said that India had seen repeated cases of grant of manufacturing license of new drugs, including Fixed Dose Combinations (FDCs), by some of the state licensing authorities (SLAs) without due approval of DCGI.

FDCs refer to products containing one or more active drug ingredients used for a particular disease indication.

“We should take such matters seriously. The people of the country should be given the best quality medicines. Such instances of unapproved FDCs getting licensed by state licensing authorities is harmful for the population,” he said.

Also read: Drug contamination reports hurt Indian pharma, government must find a way

Last year, the Centre had informed Rajya Sabha that between 2020 and 2022, state drug regulators had granted manufacturing permission to as many as 36 drugs, which did not have the central drug regulator’s approval.

Of these 36, nine were licensed for production in Himachal Pradesh and 11 in Uttarakhand.

The joint teams of state and central drug regulators conducted inspections in three sites ― Sonipat, Noida and Chennai, after drug adulteration concerns were flagged by Gambia, Uzbekistan and United States.

In all the three cases, the control samples of cough syrups and eye drops were sent to a central testing lab for detection of adulteration.

“We have been asked to keep the central authorities in the loop for any development if the manufacturing company files any response,” an official from Uttar Pradesh state Food Safety and Drug Administration said.

RA Mashelkar Committee

The government of India had set up a committee headed by Dr RA Mashelkar, one of India’s leading scientists, to examine comprehensive examination of drug regulatory issues, including the problem of spurious drugs.

Also read: WHO issues alert for 'substandard' Marion Biotech drugs linked to Uzbekistan tragedy

The Mashelkar Committee submitted its report in 2003 saying the existing drug regulatory framework was quite inadequate and weak.

“A strong, well-equipped, empowered, independent and professionally-managed CDSCO, which could be given the status of Central Drug Administration (CDA), reporting directly to the Ministry of Health, would be the most appropriate solution,” the committee said.

It concluded that such a body be headed by the DCGI.