Can doctors judge best quality in medicines?

In a surprise move on April 17, Prime Minister Narendra Modi announced that his government will soon make it mandatory for doctors to prescribe medicines by generic names. The decision was to ensure drug prices remain affordable and patients get a wider bouquet of options instead of being forced to purchase a particular brand.

Within days, the Medical Council of India (MCI), apex regulator of the sector, issued a notice reminding doctors that according to a 2016 amendment to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, they are supposed to prescribe drugs with generic names.

Doctors reacted sharply, insisting that branding of drugs assured them on quality. The Indian Medical Association (IMA) issued a statement: “The judgment to choose a rational drug and its format vests only with the Registered Medical Practitioners. This right of the medical profession is sacrosanct."

Survey on substandard drugs

As the debate about affordable medicines gets upstaged by drug safety, it is instructive to look at the findings of a recent report on substandard and spurious drugs by the National Institute of Biologicals for the Central Drugs Standard Control Organisation. Released in late February, the report established that branded medicines are in no way assurance of quality.

The report, based on a one-of-a-kind drug survey conducted from 2014-2016 and in which 47,954 samples of drugs were collected from across the country and put to test, revealed that while only 13 samples (0.024%) were spurious, as many as 1,850 samples (3.16%) were substandard. It also showed that while in retail outlets 3% of the medicines were substandard, in government pharmacies the figure was a staggering 10%. For example, as many as 26 out of 46 samples (56.52%) from the Maharashtra facility of pharmaceutical giant Pfizer Limited were found to be substandard in the survey. “Pfizer is a big name in the industry. If so many of their medicines are substandard, then it shows that big brands are no guarantee of good quality,” says S. Srinivasan of All India Drug Action Network.

Moved by the evidence from this report, the Health Ministry has initiated action against defaulting pharmaceutical companies. “We have sent notices to drug manufacturers whose products have been found substandard. Some companies have already surrendered licences,” says K.L. Sharma, Joint Secretary, Health Ministry. The ministry refused to give details of companies which have been issued notices or have surrendered licences.

Apart from Pfizer, several other famous brands might receive flak from the ministry. Twenty-three samples of Cipla Limited from different manufacturing units across India were found to be substandard in the survey. Dr. Reddy’s Laboratories Ltd. had nine substandard samples, while Zydus Healthcare Limited had six. All six out of six samples of generics major Mercury Laboratories Limited from Gujarat were substandard.

Pfizer’s spokesperson maintains only two of their samples were found substandard and that upon independent analysis, both were found to be of standard quality. “We have not been provided with any details of this report by the Government. To the best of our knowledge, samples of only two of our product were taken for this survey. In both cases, the due process of providing sealed market samples was not followed and hence the authenticity of the products picked or evidence of alleged deficiencies cannot be confirmed. Further, upon testing of control samples at independent FDA approved laboratories, both of these products were found to be fully compliant with all required specifications.  This was duly accepted by the regulatory authorities and no further action was recommended. Pfizer places the utmost importance on product quality and patient safety. All Pfizer products released in the market meet every national and international testing specification. We are engaging with the Government on this report, to better understand the details of the alleged NSQ samples, testing protocols and methodologies while also responding with these facts," said a company spokesperson.

Need for constant monitoring

Experts maintain that the government, along with the World Health Organization (WHO), must push drug companies to comply with the latter’s good manufacturing practices. “The survey is timely and is in line with the experience of treatment providers suggesting that substandard medicines — genuine drugs that fail to meet standards for quality, strength, purity or packaging — are a much bigger problem in the developing world including India and that measures to address substandard drugs are important to protect public health and patients. The capacity of the State FDAs [Food and Drug Authorities] to start performing technical evaluation before new manufacturers of older medicines are licensed, and actively identify and remove substandard drugs from the supply chain,” says Leena Menghaney, a lawyer working on access to medicines.

A one-time drug survey might not be enough. The country needs regular surveys and longitudinal studies to weed out substandard medicines from government as well as retail shops. “Regular and periodic sampling of these drugs is a must with provision for urgent analysis and follow-up action within a prescribed time limit. Periodic inspection of the suppliers is also necessary,” says M. Bhaskaran, former Drugs Controller of Tamil Nadu.

While the debate about drug safety and generic prescription of drugs is polarised, all stakeholders admit that the PM’s announcement has opened a discussion about affordable medicines that was the need of the hour.

Jyotsna Singh is a Delhi-based freelance journalist, writing on public health and policy

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Printable version | Sep 23, 2020 7:40:55 PM |

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