Question of quality

The situation is replete with ironies. In the "world’s pharmacy", as India likes to be described for supplying inexpensive generic drugs to countries across the globe, there is an all-out war on this genre of drugs. The medical fraternity and the generics manufacturing industry are up in arms against government moves to push the use of unbranded generic medicines in Jan Aushadhi stores to widen access to medicines that would otherwise be out of the reach of the poor. In India, millions who might have got out of the rut of poverty by dint of their labour are pushed back into perilous living by the high cost of healthcare, since the state provides very little support. One estimate says 7 per cent of the population drops below the poverty threshold every year.

It might seem inexplicable, therefore, that there is so much opposition to a measure that lowers healthcare costs. To the outside world, it must be puzzling why the country’s generics industry should itself be backing the campaign against unbranded generic medicines and, ironically, using the very arguments that it used to combat the power and pelf of the multinational drug companies decades ago. In one sense, it is a natural progression. Yesterday’s small and struggling generics firms are today’s biggies in the industry—a couple of them established among the top 10 in the world. Their lobby group, the Indian Pharmaceutical Alliance (IPA) represents the top 25 generics firms. In its initial years, IPA launched high-profile campaigns against global drug giants and their predatory practices, especially in the use of intellectual property, to crush the nascent generics industry. Those were the tumultuous decades when patient rights figured prominently under the strategic leadership of Dilip G Shah, who founded IPA in 1999 with just six member-firms.

Today’s IPA is a different kettle of fish. It describes itself as representing the leading research-based pharma companies in the country and plays an influential role in shaping policies that augment its growth. It speaks the same language as PhRMA, the organisation that clubbed the multinationals it once fought. It is now resisting moves by the government to allow Jan Aushadhis—it translates to medicine for the people—to substitute prescription medicines with low-cost unbranded generic medicines. The tables have turned completely. In the view of these leading generics manufacturers who enjoy huge markets in the West and at home, such a move would be detrimental to the interests of patients. IPA has warned the Union health ministry that the proposed changes envisaged by Central Drugs Standard Control Organisation (CDSCO), the central drug regulatory authority, could result in poor-quality drugs being sold in Jan Aushadhi outlets because of the faulty drug regulatory system. Currently a new company is allowed to manufacture drugs that have already been in the market for four years without a licence from CDSCO as long as it gets approval from state regulators. This is one reason why there are so many substandard products in the market. Lack of drug inspection officials is another. But it would be naïve to believe that all is well with licensed units, even those with approvals from the US Food and Drug Administration (FDA). The scandal involving malpractices at Ranbaxy, once the top Indian drug manufacturer, is a telling case.

What are Jan Aushadhis and why is there such a rumpus over a move that will only help the poor? It is a scheme launched by the Manmohan Singh government in 2008 to provide affordable generic medicines to the public, just one way to help improve the quality of affordable health care in the nation. The predatory pricing of drugs by the big-name companies meant life-saving drugs were out of the reach of India’s needy millions. When Narendra Modi’s Bharatiya Janata Party (BJP) government came to power, the scheme was repackaged as the Pradhan Mantri Jan Aushadhi Yojana. In November 2016, it was renamed the Pradhan Mantri Bhartiya Janaushadhi Pariyojana, a deliberate attempt, say critics of the regime, to carve out and highlight the abbreviation bjp. Jan Aushadhi stores sport a huge billboard of Modi but not much has been done to expand the network significantly; the number being just over 10,500.

Given the limited reach, it is surprising that the big guns of the Indian pharma sector are making such a fuss over a move that cannot be faulted except on the question of quality. It is well known that India is awash in poor quality, spurious and untested drugs, some of these manufactured purely for export. Several developing countries, one of them among the poorest in Africa, have paid heavily for sourcing cheap drugs from India. In 2022, much to the country’s shame, around 70 children in Gambia and about 18 in Uzbekistan died after being dosed with toxic cough syrup.

While these instances are indeed cause for concern, not many are convinced that IPA is speaking from an altruistic motivation. The All-India Drug Action Network (AIDAN), a network of health organisations that has been campaigning for a rational drug use policy and for availability of essential medicines under generic names, thinks commercial interests are at work here. It believes that allowing Jan Aushadhi stores to substitute brands with generic medicines would prove to millions of customers that generic substitutes “are as good as the costly brands patients were using all these days”.

In fact, when IPA claims that the permission for substitution of brand names with generic substitutes "would open floodgates of similar demands by trade channels"—meaning general pharmacy stores—and would not be in the interest of patients, it indicates what the industry’s real fears are. It does not want the generic substitution to spread from the Jan Aushadhi network to all pharmacy stores. AIDAN believes the move would help “bust the myth that only renowned brands are of good quality"—a development that can hurt the business interests of IPA members. Hence, IPA opposes the proposal on Jan Aushadhis. But equally vehement opposition comes from the medical fraternity that has petitioned everyone from the Prime Minister to the Union health minister and all departments engaged in the promotion of unbranded generic drugs. The Indian Medical Association (IMA), the largest organisation of doctors, has been up in arms since last year when the National Medical Commission issued a directive to doctors to prescribe generic medicines and warned them of penalties, including suspension of licence, in case of non-compliance. Such was the backlash against this proposal—from IMA to the Association of Physicians of India—that the order was withdrawn within days.

If CDSCO manages to push its order on generic drugs, quality will remain a critical concern. It would need a thorough overhaul of the regulatory system, from ramping up the functioning of state FDAs to vastly increasing the number of drug inspectors so as to drastically bring down the proportion of Not Standard Quality (NSQ) medicines in India to the absolute minimum. The generic revolution will not happen otherwise. DTE

Views expressed are personal