The pharma industry has asked the federal and provincial health ministries and the Drug Regulatory Authority (DRA) to launch a crackdown on counterfeit drugs mafia which is strengthening its foothold in the country since the debate of prices has emerged. "Drug industry is one of the most regulated industries in Pakistan which has led to a price freeze of most of the drugs except few hardship cases for the last 12 years. This had resulted in production of numerous drugs financially unviable and created shortage of drugs, risking lives of millions of patients," reasoned a source from local drug manufacturer.
He said it will be difficult for the industry to continue producing low cost drugs as the recent increase was given to hardship cases which were already unviable but the industry continued in hope of increase with proper channel and procedures. Now with the reversal of prices, these drugs will become unviable again and the industry which produced these drugs on loss since last few years will again find it difficult to continue to produce.
The government needs to follow the policy so that industry has a clear future, he added.
Since the government and industry's recent stand off on pricing after SRO 34(I)/2019, environment of uncertainty is encouraging counterfeiters to make the most of the situation, he added.
"It is very unfortunate that despite drastic devaluation of rupee and every sector reflecting it in their prices, the pharma industry is singled out and unjustifiably criticized for increasing prices," the source said. "We are the worst victim of rupee devaluation as almost 90 percent of raw material is imported. If a transparent and rational pricing mechanism is not in place, companies would stop making drugs, creating opportunities for counterfeit drugs."
"It is ironical that price increase of Buscopan 10 mg tablet, commonly used medicines to relieve stomach pain, from 0.93 rupees to 3 rupees is portrayed as atrocious 200 percent increase while betel nuts and suparis are available at Rs 5," he added.
Moreover, he said that the absence of specific laws, special courts and delay in justice were hampering efforts to curb the spread of substandard and counterfeit goods in the country. "A strict and forceful enforcement of existing laws is needed to control the proliferation of counterfeit products which put human lives at risk," he added.
"He said it is alarming that DRA has not yet been able to resolve fundamental issues like pricing and registrations, how will they be able to look into matters of quality and counterfeit?" he questioned.
"He said that we must learn from regional case studies of India, China and Bangladesh who have deregulated most of the drugs except life-saving to ensure availability of drug at competitive prices while focusing on quality and efficacy. This has not only benefited patients but opened doors for investment, employment and exports. Bangladesh alone has 4 FDA approved plants while Pakistan has none," said the source.
According to WHO, counterfeit drugs of malaria and tuberculosis alone result in 700,000 deaths a year globally. The counterfeit drugs contain very low API, too much API, or wrong API which make them dangerous, leading to death. Similarly, the World Health Organization (WHO) stated that up to 10% of the world's pharmaceutical trade (30% in developing countries) consists of fake medicines, while the global market for spurious/counterfeit drugs is estimated to have the value of $431 billion.