National Drug Surveys and WHO benchmarks confirm India’s medicines are top quality, safe and efficacious

According to IDMA, the result of the survey will put to rest speculations of vested groups about the alleged substantial presence of spurious drugs in the country

The consumers have a right to access drugs that are safe and of good quality and the Indian pharmaceutical industry, the Government of India and other stakeholders are committed towards ensuring it

The Ministry of Health and Family Welfare undertook a landmark Survey conducted between 2014 and 2016, considered to be the largest ever survey in the world to determine the quality of drugs manufactured in India. The survey focussed on Not of Standard Quality Drugs (NSQ) and spurious drugs. Samples were collected from all over India and the report of the survey published recently reveals that the extent of NSQ and spurious drugs for retail outlets and government sources in the country was estimated to be 3.16 per cent and 0.0245 per cent.

“A total of 47,012 samples were analysed of which eight samples (0.023 per cent) from retail outlets and five samples (0.059 per cent) from government sources were found to be spurious. The survey also revealed that most of the samples tested NSQ were due to non-compliance in dissolution and assay,” said Daara Patel, Secretary General, IDMA pointing out the significance of the survey.

“This survey reiterates the study conducted by CDSCO in 2008-09 of over 24,000 samples considered the largest survey ever at that time. Of the 24,000 samples tested, only 10 samples were found to be spurious, though the number could be much less, as there was no effort to distinguish between NSQ and spurious drugs in the survey,” he said. Also, a World Health Organisation (WHO)-sponsored study by SEARPharm, was conducted earlier covering over 10,000 samples, which found that only 0.3 per cent of drugs were spurious.

What is cause for concern is the misinformation being spread by vested interests about the extent of spurious drugs in India. Though ideally not even one drug should be spurious, but globally spurious drugs are noted to be present even in highly developed pharma markets.

“The results of these drug surveys confirm the quality of pharma products uniformly approved and manufactured in India for patients all over the world. The result of the survey must put at rest all speculations of vested groups about the alleged substantial presence of spurious drugs in the country,” emphasised Deepnath Roy Chowdhury, National President, IDMA.

The WHO had conducted their assessment of India’s National Regulatory Agency (NRA) earlier this month. It is very heartening to note that the benchmarking conducted by WHO was in respect of nine different functionalities. The NRA includes the Central Drug Standard Control Organisation (CDSCO), which comprises the offices of DCG(I), zonal offices covering all Ports, all State FDAs, Pharmaco-vigilance Programme of India (PvPI) and Adverse Events Following Immunization (AEFI) structures at the Central and States levels. Congratulating the Minister of Health and Family Welfare and the Drugs Controller General of India, on this unique achievement.

Deepnath Roy Chowdhury said, “It is a real credit to our robust regulatory system that the NRA has been declared ‘functional’ with the highest maturity levels as per currently evolved definitions.”

India’s vaccines regulatory system has also been assessed with “100 per cent compliance” by WHO. It reaffirms our stand that our affordable generic medicines and vaccines are of top quality as approved by our NRA that has the highest levels of maturity. India is also the global leader in production and supply of vaccines.

This further strengthens confidence in pharma drugs and vaccines both locally and globally. “It highlights the fact that the Indian regulator and pharma industry have jointly been working wonders in providing affordable quality products which are safe and efficacious to our people as well as citizens across the globe,” concluded Patel.