The Drugs Act

Substandard pharmaceuticals have been a nagging issue that is yet to have been sorted out by the country’s political authorities. Despite the existence of some basic laws governing the standards of pharmaceuticals, Pakistan has never had a strong regulator for pharmaceuticals being produced within the country or imported from abroad. 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.
Step forward, Punjab. 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. The ordinance recognises a number of ‘foreign drug authorities’ for imports. It has approved the creation of one or more provincial quality control boards, but how provincial boards will check the quality of imported drugs that usually come in through the Karachi port is another major loophole. Another key issue may be sale of drugs imported by one province in another and how this will be checked. The ordinance may be well intentioned, but is a rushed one. There needs to be serious consultation before new provincial regulations are passed to ensure quality medicines reach the sick.