At a recently held international conference in New Delhi on patient safety and drug detection technology, consumer groups asked for introduction of technologies to protect patients from spurious drugs. The meeting was organised by Partnership for Safe Medicines India, an association of consumer groups in India along with the ministry of health and family welfare.
While the organisers insisted on bringing in technology currently used by individual pharmaceutical firms to protect their drugs from being counterfeited to the government for wider application, civil society groups working on health say that this might not work and drew attention to the larger issue of sub-standard drugs reaching the patients.
According to Bejon Misra, founder board member of Safe Medicines India, bridging the technology gap between the pharmaceutical industry and the government can solve the problem.
The health activists, on the other hand, stressed that drug detection technology alone cannot solve the problem of spurious drugs. Quality of drugs has to be ensured at every stage of the supply chain as drugs manufactured using WHO’s Good Manufacturing Practices (GMPs) may also get contaminated at retail outlets if they are not stored in suitable conditions. These drugs may be fatal for patients using them, they added.
Sub-standard drugs: a problem across the world
Leena Menghaney, campaign coordinator of Medicins Sans Frontieres (MSF) India said that her organisation comes across drugs manufactured even from the US and the EU besides India, which are sub-standard. “Technology is only one part of ensuring drugs’ quality. Larger issue that countries are facing today are of sub-standard and spurious drugs, not counterfeit drugs,” she said.
Under international law of Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), counterfeit drugs are defined as wilful infringement on trademark on a commercial sale. India’s Act for regulating drugs, Drugs and Cosmetics Act, does not use the word counterfeit to define poor quality drugs. Instead, it uses terms like adulterated, spurious and fake drugs.
Elaborating on the issue, Amit Sen Gupta of People’s Health Movement, a group of health non-profits, said that the bar code numbers on drugs can only trace who the manufacturer of the drug is and is helpful in identifying counterfeit drugs. But if the drug is of poor quality or contaminated, no one takes responsibility. “Mapping of incidents of spurious drugs and health systems in the country is needed,” he said.
“This technology of tracking and tracing drugs benefits pharmaceutical companies more than the patients,” said Menghaney. “If these companies use any such technology, the price of the drug will go up which will make them more expensive for patients,” she explained.
DCGI to be strengthened
To ensure quality drugs reach the patients, the Union health ministry is in the process of enhancing its drug testing technology, manpower and funds under the Drugs Controller General of India (DCGI). The issue of sub-standard drugs looms large in the country and often lack of manpower and infrastructure capacity of the DCGI office is raised.
Joint secretary in the Union health ministry, A K Panda, informed that the Centre will be able to use Rs 2,000 crore in the next few years under the 12th five-year plan that can be used to assist states in enhancing their infrastructure for effective ways of checking spurious drugs. “The funds will be used for more drug inspections, better equipment and laboratories,” he said.
Meanwhile, the Union health ministry is sticking to its law and is planning to go by the age old practice of randomly testing drugs from various sources. “With increased funds, we expect more number of good drug inspectors, better labs and increased number of samples getting tested for any kind of adulteration,” said a senior official of Central Drugs Standard Control Organisation (CDSCO).
Another issue that the Union health ministry is struggling with is lack of data on poor quality drugs. There is no data in India on how many drug manufacturing units are operating in the country and what the status of their GMPs is.
There is also a wide variation in the figures floating on the share of spurious drugs in India. According to the Union health ministry only about four per cent of the total drugs are sub-standard and 0.04 per cent drugs are spurious. WHO so far has no data on how many fake medicines come from India. “WHO’s figure of 40 per cent fake medicines coming from India that is quoted in the media is false,” said Madhur Gupta, technical officer, pharmaceuticals, WHO.
The consequence of this false information can be huge as India is a major exporter of generic drugs, said Surinder Singh, former DCGI. “Indian generic medicines go to more than 200 countries. There is a loss of credibility in the international market if such highly distorted figures are floated,” he said.