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The US investigation into the Ranbaxy and Wockhardt manufacturing facilities in India has turned the spotlight on the quality of drugs in the domestic market.
The pharmaceutical industry may be growing, but some of its practices are ailing. These less-than-perfect practices have come to light thanks to the US regulatory authorities looking into companies such as Ranbaxy and Wockhardt. The spotlight is now on the quality of drugs available in the domestic market.
Doctors, stockists and industry experts have raised concerns about the manufacturing facilities and the distribution chain. They say medicines may be of poor quality not only because of the manufacturing process but also because of unsuitable distribution and storage at shops.
The two problems relating to quality are substandard drugs and fake drugs. Substandard medicines are genuine drugs that do not meet the standards set for them with regard to quality, strength, purity and packaging. Fakes are those manufactured with criminal intent, by deliberately and fraudulently mislabelling drugs, giving false representation of identity and/or source so that they are considered genuine medicines.
The main problem in India is substandard drugs. In Maharashtra, for instance, of the 8, 000 samples tested by the state Food and Drug Administration, around 8 per cent were found to be "not of standard quality". Another study in Tamil Nadu said about 7 per cent of 4, 110 drugs tested was substandard.
Experts say that the problem is hugely underestimated. Dr C M Gulati, editor of medical journal MIMS, says this is due to a faulty system of sample collection. "Poor quality control onitoring, both in-house and by regulators, is the core problem, " he says.
Last year, media reports quoting Tamil Nadu drugs controller G Selvaraj said drugs for diabetes, high blood pressure and heart disease, as well as vitamins, steroids and cough syrups were found to e of inferior quality. For instance, samples of prednisone, a steroid administered for respiratory disorders and pain relief, taken from the government supply had 'nil' content of the active ingredient.
Across the country, widely-prescribed drugs made by multinationals and large domestic companies have been found substandard as per reports from state drug regulatory authorities, says Dr Gulati, adding that the contamination may be happening during distribution or storage.
Substandard drugs may not be harmful like fakes, but they do not yield the desired effect because they may not have the prescribed strength of the active ingredient or may be contaminated. Besides, they may undergo accelerated deterioration because of poor quality packaging, or not being stored at a particular temperature. If injections, insulin and certain pills are not stored at the appropriate temperature, it may reduce their efficacy.
Few companies have the mandatory quality control laboratory, as these are expensive to install, run and maintain. According to the Drugs and Cosmetic Rules, inspectors should conduct a detailed review of quality assurance systems at least once a year. Sources in regulatory agencies as well as companies admit in certain cases inspections can be "managed".
Regulations do exist, but the problem is implementation. The Drugs and Cosmetics Act, 1940, lists guidelines under Schedule M for manufacturing, processing, warehousing, packaging, labelling and testing of medicines.
Ranjit Shahani president, Organisation of Pharmaceutical Producers of India, an industry body which represents multinational companies, says, "The quality of medicines available in the country is highly variable. At one end, there are plants with global standards and at the other, those that are literally holein-the-wall operations, and not schedule M-compliant. What can be more important than health? Yet, you always hear authorities say they lack resources and inspectors to audit facilities. "
A parliamentary panel on health last year said the country had about six lakh retail outlets and 10, 500 manufacturing units, which require more than 3, 200 drugs inspectors. However, there are only 846 drugs inspectors as against 1, 349 sanctioned posts in the states. The main problem faced by state drug authorities is inadequate infrastructure, shortage of drugs inspectors, non-uniformity of enforcement among states, and lack of interaction between states particularly in connection with investigations relating to substandard drugs (see chart).
The Rs 72, 000-crore domestic market is hugely fragmented with around 30, 000-odd formulations. While the Centre frames broad guidelines and approves new drugs, state drug authorities are entrusted with issuing manufacturing licences, inspecting plants, and collecting and testing samples both from drug plants and retail outlets. The parliamentary committee noted that there are serious shortcomings in Centre-state coordination in the implementation of the act.
Another reason for drugs being substandard is improper transportation and storage. In semi-urban areas, chemists do not have functioning refrigerators, while in remote towns and villages there is no power for hours. "A pharma product that has not been stored at the right temperature is as good as counterfeit, " says Shahani.
Even after an anomaly is detected in the sample, a large number of packs may have been sold causing indeterminable harm to patients. There is no method to recall unsold stock once it is in the distribution network or in stores.
Most formulations are manufactured in one state and sold in others, but the responsibility of quality assurance rests with the state where the plant is located. Certain states like Himachal Pradesh, Daman & Diu and Sikkim have large number of factories, but a small drug control administration. Industry experts say states like Maharashtra and Kerala have relatively better manufacturing standards as well as stringent surveillance and monitoring by regulatory authorities.
Since drug authorities are funded by state budgets, there is not only paucity of funds but also lack of will to spend money on quality assurance for products that are "exported" to other states, says Gulati.
"To ensure medicine quality, India's drug regulatory authority must be strengthened to overcome the shortfalls highlighted in a May 2012 Parliamentary report on India's national drug regulatory authority. To achieve this, the government must provide appropriate levels of staffing, financial resources and technical support, " says Leena Menghaney of international medical humanitarian organisation Mêdecins Sans Frontires, which procures drugs from India.
India, tagged as the 'pharmacy of the world', has a larger responsibility to ensure quality as it manufactures drugs for its own people as well as millions across the world.
WHAT'S LIKELY TO BE SUBSTANDARD...
Suspensions and syrups due to problem of inadequate mixing ingredients with liquid used, micro bacterial contamination, poor quality water, defective caps etc Enzymes (such as serratiopeptidase), and vitamin D-3 are easily degradable Certain antibiotics Temperature sensitive products such as insulin, vaccines, sera etc Near-expiry formulations
DOPE ON DRUGS
There is no inspection of raw materials, particularly those imported from countries with poor drug regulation. Raw material is supposed to be tested (potency 97 to 103% mandatory) before use but hardly any monitoring Emphasis on end product but no continuous process of quality control during manufacturing Inadequate monitoring due to insufficient technical staff (regulators) for over 10, 000 drug manufacturing units Lack of monitoring in transport chain and storage - from factory to distributor to retailers All medicinal packs carry instructions: "Store in cool, dry place" or "Store at temperature not exceeding 30 degree C. India follows shelf-life guidelines as stipulated in cold climate countries. Due to hot, humid weather and storage problems, shelf life guidelines need to be re-worked.
Better monitoring and inspection by companies, and stringent audits by regulatory agencies. Companies need to invest in well-equipped quality control labs Inspections need to be done at distributors' end as well as at retail stores on a regular basis Inspection and testing of raw material (bulk drugs) should be carried out at the point of entry when imported Infrastructural bottlenecks like transportation, supply of power, storage of medicines while in transit and at retail stores, need to be removed Put in place an effective system of recall of drugs Govt needs more inspectors and labs.
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