By Invitation . Keeping an eye on quality

India is looking to increase the import duty on APIs (active pharmaceutical ingredients) to boost its local capacity and lower its dependence on imported medicinal drugs. India imports around 70 per cent of its raw material, and an effort is underway to reduce its dependency on APIs sourced from China.

The move may boost local production of drugs, helping India become atmanirbhar (self-reliant). However, given that only one-fourth of the 12,000 manufacturing units comply with the World Health Organization’s good manufacturing practices, India isn’t ready to implement an inward-looking approach as this could pose the challenge of substandard drugs. A 2015 survey by the Central Drugs Standard Control Organisation found that 4.5 per cent of all generic drugs in India is fake or substandard.

India has been battling the scourge of spurious and low-quality drugs for years. The problem came to the fore when five medicines were recalled due to quality lapses within 20 days of the government launching the Jan Aushadhi Scheme in November 2008. The number rose to 11 in four months — that is, by March 2009. According to a 2017 report by the WHO, “about 10.5 per cent of medicines sold in low- and middle-income countries, including India, are substandard”. This figure is startling at a time when the world is battling a pandemic and there is a shortage of basic medicines.

Over-the-counter drugs are at higher risk of failing quality standards. A 2015 study published in the Journal of Applied Pharmaceutical Science and another published in the International Journal of Pharmacy and Pharmaceutical Sciences in 2016, cite the examples of popular painkiller diclofenac sodium and antibiotic amoxicillin trihydrate, which were found to be substandard. This is alarming given that India reported an increase in human antibiotic consumption from 3.2 billion defined daily doses in 2000 to 6.5 billion in 2015.

Additionally, as substandard drugs work less effectively, they cause the disease to run a longer course, necessitating new prescription at times.

Besides having an adverse impact on overall healthcare, substandard medicines can also tarnish India’s reputation in the global pharmaceutical market. There are only 47 drug testing facilities and six central labs, testing 8,000 samples per year. Further, India has only 20-30 laboratories that check the quality of drugs. To meet the rising demand for superior quality drugs, there is a dire need for more such laboratories; India is ramping up its infrastructure for testing and manufacturing.

To get to the root of the quality problem, the Drugs Controller General of India (DCGI) needs to work closely with pharmaceutical companies and the local drug control authorities. The problem can be tackled, keeping patient safety as priority, if a joint effort with defined protocols is followed. In India, when a doctor or patient raises a complaint about a drug produced by a pharmaceutical company, the regulatory authority raids the medical shop and takes a sample of the drug for quality checks. The results are received by the DCGI and a directive is released without any discussion with the State drug regulators or the pharmaceutical company. The directive labels the drug as ‘Not of standard quality’, which complicates the issue, as there is no differentiation between substandard drugs and fake or falsified drugs. A substandard drug, for example, has a low percentage of API, while the fake has none at all.

It is important that the seller of the falsified or fake drug be punished after investigation.

Fraudulent agents sell fake drugs under the name of a pharmaceutical company, which may be unaware of it. If India wants to maintain its reputation in the global pharmaceutical market, the Ministry of Commerce and Industry will have to address the quality issue.

We need more transparency and enforcement of stringent processes once a medicine is found to be of suspect quality. As of now, the loop rarely seems to be closed on this topic as the source of the falsified drug remains unchallenged and the people responsible are not brought to task. Already several drug regulators around the world have given feedback regarding the quality of drugs manufactured in India. Now, the country needs to combine a strong regulatory regime with an investor-friendly environment to encourage global and Indian companies alike, and ensure that patients have access to superior quality drugs and treatment.

NK Ganguly

The writer is a former Director-General — Indian Council of Medical Research. Views are personal

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