Under harsh flickering lights in a room lined with hard plastic chairs, a man rolls up a small discreet paper sachet filled with tiny pink and white tablets and slides it across the counter. Large translucent plastic bottles filled with different colour fluids line his counter along with smudged tan containers with heaps of capsules and pills.

Though the scene is reminiscent of a low-budget indie movie on contraband narcotics, it is nothing more than the neighbourhood compounder doling out medicines based on the family doctor’s prescription. Reading the illegible writing of the doctor, the compounder mixes up a concoction of liquids and fills a small white bottle to be taken at night before going to bed.

While those in the West may shudder at the thought of gulping down a tablet of unknown origin and unknown purpose, the eco-system of the pharmaceutical sector in Pakistan is such that this is a practice most have grown up with.

Outside Civil Hospital and Dow Hospital, empty capsules are sold in bags of 50 for Rs100 along with hundreds of tiny white tablets in one-pound bags for Rs80. These can be used for any purpose by doctors, pharmacists or hakeem, the shopkeepers explain.

Both local and global players want the regulator to limit its role to quality checks and, barring essential drugs, leave pricing to the market

‘Katchi Gali’ near Marriott Road is a well-known hotbed for spurious medicines. In a locality where goats munch hay next to carts loaded two feet high with slabs of chocolate, vendors sell a smorgasbord of counterfeit products. Not the least among them are fake medicines manufactured in dirty backstreet labs in narrow alleys.

While it may be hard to gauge the extent of damage wrought by these spurious medicines, the incident that took place about a decade back gave rise to the much-maligned pharmaceutical regulator.

The history

In early December 2011, patients bleeding from the mouth and gastrointestinal tract were presented to hospitals in Lahore. By mid-January 2012, 25 people had died, a number that would rise to over 200 with another 1,000 becoming seriously ill.

The cause was traced back to locally manufactured cardiovascular medications that had been distributed freely by the Punjab Institute of Cardiology in Lahore. With assistance from the World Health Organisation (WHO), the containment was identified as large quantities of antiparasitic drug pyrimethamine that had been accidentally mixed in a batch of a medication called Isotab.

The incident led to the Drug Regulatory Authority of Pakistan (Drap) Act of 2012, which established the regulator under the Ministry of National Health Services, Regulation and Coordination (NHSRC).

“It is not an empowered independent body,” laments Kaiser Waheed, former chairman of the Pakistan Pharmaceutical Manufacturers Association (PPMA). Sighing over PPMA’s dream, he said Drap should be as autonomous as, for example, the National Electric Power Regulatory Authority or the Pakistan Electronic Media Regulatory Authority.

The Senate, however, changed the law and put it under the Ministry of NHSRC, effectively rendering it toothless. As a result, each decision has to be vetted by the ministry for bureaucratic clearance. “It can take two years before the Senate can enact changes requested by pharmaceutical stakeholders,” says Pharma Bureau Executive Director Ayesha Tammy Haq. “A patient could be dead before the approval required for his medicine is made.”

The cost of a toffee

Highlighting the need for competition, Mr Waheed gave the example of Montelukast, a medicine used for energy and asthma. A couple of years ago, the price of a single tablet was Rs80. However, competition drove down the price to Rs2-3 per tablet. “Let market forces control prices, the regulator should not,” he said.

Some research indicates that about 40-50 per cent drugs available in Pakistan are counterfeit, a figure quoted by a dated study by the Aga Khan University, Karachi, funded by WHO and published in 2011. “If half the medicines available are spurious, there would be fatalities all over Pakistan,” laughs off Mr Waheed. “All government hospitals purchase medicines by local manufacturers because of budget constraints. If so many medicines were fake, there would be bodies lining the corridors.”

Medicines by domestic manufacturers receive flak from their international counterparts for not being certified bioequivalent — a process through which generic drugs are proven to work in the same effective way as brand-name drugs. However, the cost of such a process runs to millions of dollars.

“Life expectancy used to be 51 years in 1967; now it has risen to 67 years, although the water we drink is contaminated and the air we breathe is polluted. The main reason is the access to affordable medicine made possible by local manufacturers who cannot opt for expensive certifications if they want to keep the prices of drugs reasonable,” says Mr Waheed, firmly attributing the rise in life expectancy in the country to the increase in the local competition.

“A big chemist has every kind of medicine on his shelves, but you cannot be sure whether it is a genuine product or smuggled into the country in someone’s suitcase,” says Ms Haq. Under the regulatory environment, a drug that is being manufactured in the country cannot be imported. However, grey channels ensure its availability through khapias.

The main bone of contention between domestic manufacturers and multinationals is that the latter follow international practices that push up prices of their branded drugs while the former can afford to make cheaper meds by not having such checks and balances in place.

But both players agree on one thing — the regulator should limit its role to quality checks and, barring essential drugs, leave pricing to the market. Local and international manufacturers concur that overregulation has severely curtailed the growth and potential of the sector, an allegation that Drap has not responded to despite repeated attempts to contact its officials.

Published in Dawn, The Business and Finance Weekly, March 29th, 2021