It is common for patients to stop taking medicines as soon as they start feeling better. Doctors have blamed this particular habit — of not completing the entire dose of antibiotics — to the emergence of drug resistant strains in diseases such as malaria and tuberculosis (TB). However, experts say that under-dosing, or the use of poor quality medicines, could be accelerating this drug resistance. Seen this way, India — which is one of the world’s largest manufacturers and exporters of generic medicine — could be contributing to the rise in drug resistant strains of diseases.
“India’s proud to call itself the ‘world’s pharmacy’, and it should be. But it comes with a huge responsibility,” says Dr. Elizabeth Pisani, epidemiologist at the London School of Hygiene and Tropical Medicine. “If the world’s pharmacy is selling poorly-made products — if they’re selling crap, to put it bluntly — then sick people don’t get cured; they may even die.”
India could take a lot of credit for supplying affordable medicines to treat TB and malaria around the world. But this progress is being “reversed” because of growing resistance, and India “has to take some of the blame” due to medicines that “don’t work very well, medicines that cut corners on active ingredients or don’t dissolve correctly… superbugs are spreading,” says Dr. Pisani.
Results of JAMA study
The World Health Organisation (WHO) estimates that one in 10 medical products sold in low- and middle-income countries such as India are either substandard or falsifiedSF.
A recent study in the Journal of the American Medical Association found that 12.4% of antibiotics and 19.1% of antimalarials in such countries were SF. WHO defines “substandard” medicines as products that are “out of specification” — products that have degraded since they left the factory during transportation or storage and fail to meet quality standards. Falsified drugs are medical products that deliberately/fraudulently misrepresent their identity, composition or source. SF medicines can cause serious (sometimes fatal) injuries to patients; they can prolong an illness due to wrong dosage or the lack of an active ingredient, which could result in emergence of drug resistance.
In the November 2015 edition of the Review on Antimicrobial Medicine , Dr. Pisani noted that “every shred” of available evidence suggested that poor quality medicines were contributing to the development of drug resistant pathogens in lower income countries.
Chloroquine, for example, is often used in place of newer antimalarials, delivering the customary bitter taste and perhaps reducing fever, but not effectively clearing parasites. Also, standards set by India’s national drug regulator, the Central Drugs Standard Control Organisation (CDSCO), are partly to blame. Dr. Pisani notes: “The CDSCO suggests that medicines can be short of up to 30% of the active ingredient before they are considered seriously sub-standard — that’s three times the shortfall generally allowed for most anti-infective medicines in the British or U.S. pharmacopeia. Indian manufacturers who persistently churn out medicines with just 70% of the advertised active ingredients may suffer administrative sanctions, according to the official guidance, but it recommends against prosecution.”
Dinesh Thakur, the whistle-blower who exposed data manipulation by Indian drug maker Ranbaxy in 2013, says that unless the Drugs and Cosmetics Act is amended to include severe penalties for those manufacturing substandard drugs, nothing will change. “Dr. Pisani’s assertion is linked to the guidance the CDSCO has put out that there could be a variance of +/- 30% in dose response for generic drugs to be sold in India. As a regulatory response, the first step should be to tighten our specifications to not allow substandard drugs on the market.”
Lack of engagement from the CDSCO was a consistent talking point at the week-long and first-ever academic conference on ‘Medicine Quality & Public Health (MQPH)’, in London, in September.
Dr. Pisani cautions: “Right now, a lot of companies appear to operate on a ‘let’s see what we can get away with’ basis. If they are shipping to the European Union, the products are of top quality. But if the medicines are going to Niger, where they probably won’t get checked, companies tend to cut a few corners in production or packaging. It really makes no sense to put the onus for quality control on 192 countries, when one country is producing medicines for so many of them. China is beginning to challenge India for the title of the world’s pharmacy, and Beijing is paying a lot more attention to quality control than Delhi is. So, you can guess which pharmacy the world is going to start shopping at soon.”
The CDSCO did not participate in the conference and the Drug Controller General of India (DCGI), Eswara Reddy, did not respond to queries from The Hindu , on India’s position on the subject.
Vidya Krishnan is a freelance journalist. E-mail: email@example.com
If the world’s pharmacy [India] is selling poorly-made products, then sick people don’t get cured; they may even die.”
Dr. Elizabeth Pisani,
London School of Hygiene and Tropical Medicine, London