Regulatory challenges in the pharmaceutical sector have emerged over time due to under-resourcing of regulatory institutions and weak accountability mechanism. These systemic constraints need to be addressed as a priority in order to achieve access to quality medicines; notwithstanding, we also need disruptive solutions, which have potential to spread a contagion of ethical behaviour in the entire pharmaceutical value chain. In order to tackle sub-standard drug issue by pharmaceuticals a massive campaign about reading labels, using trusted pharmacies and reputable sources has to start immediately at the national, provincial and municipal level. The awareness campaign needs to be linked with strengthening of quality control mechanisms by the government. This means not only testing the drugs that enter the market, but also tightening the supply chains.
The few laws that exist, such as the Drugs Act, 1976, remain weak in terms of the actual punishment that producers, importers or sellers of fake drugs would face. The threat to the health of the population is a significant one, with no estimates of how many counterfeit products are on sale at pharmacies around the country. After the 18th Amendment, regulation of pharmaceuticals became a provincial subject. A number of observers warned that this would be a dangerous precedent, since even the US, being one of the most deregulated federations in the world, has a Federal Drug Authority (FDA). Each province would now have to produce its own drug regulations and its own regulatory authority. On Thursday, the Punjab government amended the Drugs Act, 1976, through the Punjab Drugs (Amendment) Ordinance (2015) to increase the punishments for producing or selling fake drugs, and introduced a procedure for undertaking such investigations. While the ordinance is a positive step, there are a number of questions this raises, including the very basic question of: why did Punjab pass an ordinance, instead of an act of the Punjab Assembly which is controlled by the PML-N? If Punjab had not passed a drug regulation law for so long, then would the correct process not have been to have it run through a parliamentary sub-committee before becoming an act of law? The reason is also a number of questionable provisions in the law, such as removing the word ‘substandard’ to only deal with ‘spurious’ drugs. That raises the question: are substandard drugs going to be considered spurious or not? The law allows for registering FIRs in such cases and requires mandatory police investigation with the the government allowed to file an appeal against the drug courts’ verdicts. Punishment for importing spurious drugs or selling temperature sensitive drugs in conditions that cause them to lose potency could be up to 10 years in jail, with minimum of five to three years depending on the offence. There needs to be serious consultation before new provincial regulations are passed to ensure quality medicines reach the sick.
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