India Set For New Study On Spurious Drugs

India continues to move towards improved regulatory oversight in the pharmaceutical segment. It has now initiated steps for a new study on spurious drugs and plans an expansion in the number of adverse drug reactions (ADR) monitoring centers in the country.

The Deputy Drugs Controller of India, K. Bangarurajan, said that the regulator was working on the contours of the study on spurious drugs in consultation with the Indian Statistical Institute.

''About 15 pharmacological categories have been shortlisted and the study will entail collection of samples and analyses before the actual report generation,'' Bangarurajan said in response to specific queries from Scrip at the sidelines of the recent 17th Pharmaceutical Analysts' Convention organized by the Indian Drug Manufacturers' (IDMA) in Mumbai.

Surinder Singh, a former drugs controller general of India and currently director of the National Institute of Biologicals, an autonomous institution under India's ministry of health and family welfare, is the convener of the study.

Some local media reports suggested that the study may involve more than 40,000 samples being drawn across the country, with about INR 85 million ($1.39 million) having been already sanctioned towards the exercise.

The new study assumes significance following international concerns over the menace of spurious drugs and also a generally oft-quoted but inaccurate statistic that one in five drugs made and distributed in India is "spurious" – a finding often attributed to a non-existent WHO study.

India has previously referred to a WHO clarification on Aug. 31, 2012, that maintained that there was no such study carried out by it.

A previous Indian government survey report in 2009 had stated that the extent of spurious drugs in retail pharmacies was 0.046 % (11 samples out of 24,136 samples).

The survey included samples of popular brands of oral solid dosage formulations from nine therapeutic categories including anti-infectives, anti-malarials, anti-TB drugs, steroids, cardiovascular drugs, anti-diabetics and multivitamins, which were collected between November and December 2008, as per details in the 2009 government report on the countrywide survey for spurious drugs.

Inspections And ADRs

Bangarurajan also indicated that local inspectors routinely participated as observers in inspections by international regulators in India, including a recent audit by the Irish regulator.

''Such joint efforts improve the skills of our inspectors and we are also giving continuous training,'' he said.

Earlier this year the U.S. FDA and India's Ministry of Health and Family Welfare had signed a statement of intent on co-operation in the field of medical products, largely focused on information sharing though it also mentioned that respective regulatory authorities be informed prior to undertaking inspections, so that host-country inspectors may join such inspections as observers (Also see "As U.S. FDA Chief Hamburg Commences India Visit, Government Bats For Generic Industry" - Scrip, 10 Feb, 2014.).

Bangarurajan in his address at the IDMA event also referred to a recent conference of drug regulators in Brazil, where officials discussed issues around the uniformity of good manufacturing practice (GMP) inspections, whether inspectors have the same level of competitiveness and whether inspections of one country could be accepted by another to avoid multiple audits (Also see "India’s Second Stab At Whistle Blower Policy To Curb Spurious Drug Trade" - Scrip, 21 Jul, 2014.).

The deputy drugs controller also highlighted plans to expand ADRs monitoring centers under the Pharmacovigilance Programme of India (PvPI) from 150 currently to cover all 384 government medical colleges going forward.

The program started out with 22 ADR monitoring centers in 2010 and this was subsequently increased to 90 by the end of 2012. PvPI works in collaboration with the global ADR monitoring center, WHO-Uppsala Monitoring Centre (UMC), Sweden, contributing to the global ADRs data base.

The UMC has, since 1978, managed the primary aspects of the expanding worldwide pharmacovigilance network of over 130 countries under the WHO Programme for International Drug Monitoring.

India's overall capacity building efforts come in the backdrop of stringent US FDA action against a clutch of domestic firms over cGMP deviations, prompting global comments that the national regulators need to play a much more proactive and authoritative role in ensuring quality and consistency of medicines in markets like India.

Earlier this year, India said that it expected to double the number of regulatory personnel to 1,000 at the central level, while about 3,000 officials will be part of the state level effort (Also see "India Plans Tighter Enforcement At State Level To Counter Spread Of Spurious Drugs" - Scrip, 11 Sep, 2012.).

[Editor’s Note: This story originally appeared in Scrip Intelligence.]