September Issue 2008

A thriving industry of counterfeit medicines has spread its tentacles all over Pakistan. The issue, which has been highlighted repeatedly in the media and at other forums, has so far failed to take precedence with the concerned authorities, and the industry has only multiplied over the years.

According to the World Health Organisation (WHO), 40-50% of the medicines in Pakistan are counterfeit. Members of the pharmaceutical industry say this figure is exaggerated and some of them have requested the UN to investigate the matter further. However, they do concede that a large counterfeit industry operates in Pakistan. Off the record, government officials say that this industry is vast and difficult to control. On record, they state it exists, but on a small scale.

As for statistical data, there is no correct figure to indicate the extent of the problem. The lack of statistics is partly due to the variations in definition. Medicines that are defined as counterfeit globally are defined differently under the Drug Act of Pakistan, according to which, a drug is described as ‘counterfeit’ if its outer packaging resembles or is an imitation of a drug manufactured by another company. The term ‘spurious’ is applied to a drug which does not contain the active ingredient that should be present in the drug, or that is said to be manufactured by a certain company or country but is actually not made there, or that it is labelled as one drug and sold as another. Then there are also medicines that are defined as ‘substandard,’ ‘misbranded’ and ‘adulterated.’ All these combined sum up the global definition of ‘counterfeit.’

Medicines, whether counterfeit, spurious or substandard — as per the Pakistani definition — are either made locally or smuggled into the country. Manufacturing them is a relatively easy and an inexpensive job. To make tablets, for instance, tableting and blister machines are available for a few lakh rupees. These machines are set up in one-room apartments or houses. The innumerable printing shops in every nook and corner of the cities are used to design and print the outer packaging.

The Faisalabad-Multan belt and other areas of the lower Punjab have been identified by members of the local pharmaceutical industry as being notorious for such activities.

Counterfeit and smuggled products are available at drug stores in the cities, while spurious medicines are available at the wholesale markets.

Smuggled medicines come in from China and India, and some are also brought in from Dubai. There are three main channels for smuggling: the borders, containers, and personal baggage. Previously, the Afghan transit trade facilitated the smuggling of medicines, as trucks with a consignment for Afghanistan would travel through Pakistan unchecked, to be unloaded at the Afghanistan border, and then medicines were loaded on the same trucks and brought into Pakistan.

At present, smuggled medicines are available both as packed medicines and medicinal ingredients to be used for manufacturing purposes. “Suppose a person has a business of electronics and he has a container of 100 tonnes coming in, he can easily bring 20kg of medicines, illegally, along with that. So the immigration authorities and the FIA need to check the contents of the container, instead of just weighing it,” says a federal official.

The federal ministry of health holds the FIA and the immigration authorities responsible for initiating action against the smuggling of medicines. The federal ministry’s job, according to them, is only to point out the problems to the relevant authorities. While it may be the FIA and the immigration authorities’ responsibility, the ministry does not follow up on their own recommendations, the reason being that the FIA and immigration officers apparently do not share their information.

In addition to smuggled and manufactured medicines, Pakistan, like other developing countries, has become a dumping ground for medicines that are otherwise not allowed to be sold in the developed countries. Medicines approaching their expiry or those that simply do not meet international specifications find their way into the Pakistani market.

For drug monitoring purposes, every provincial government has drug inspectors who collect random samples from manufacturers, shops and wholesale markets. These samples are then sent to drug-testing laboratories, where they are tested for their quality and efficacy.

Many contend that there are too few drug inspectors for effective surveillance. Of late, the federal health ministry has sanctioned an increase in the number of drug inspectors for each province, but much more remains to be done.

While urban areas are still easier for the drug inspectors to monitor, the rural areas, where the bulk of spurious drug manufacture takes place, are out of bounds. There are many reasons for this. Firstly, drug inspectors do not have transport facilities, an expense budget or a police task force to aid them in their raids. When a drug inspector seizes samples from somewhere, he needs to get the signatures of witnesses — and there are not many volunteers for that. People fear for their security because those involved in this business are influential people: tribal lords in the villages, and business tycoons and others in the cities. Thus, with no witnesses and no transport to send the seized sample across to the labs, those inspectors who make the effort often find that their efforts are in vain, while others become susceptible to bribery, especially keeping in mind their own low income.

Another problem is that the small fry tend to be caught while the big fish remain at large. Officials reveal that it is impossible to collect samples from hospital pharmacies and from the large ‘reputable’ pharmacies of the cities. They make sure no drug inspector dares to step into their territory, and if one does, it is only minutes before he receives a phone call telling him to leave — and that call has, on occasion, come from the federal health ministry.

While power grants cover to some, sheer speed is the tool of escape for others. Some areas where these medicines are manufactured and sold are known to pharmaceutical manufacturers, drug inspectors and shopkeepers alike. For instance, in Karachi, Dehli Colony and Katchi Gali have been identified as areas notorious for this business. But this knowledge does not always lead to action. An official of the Sindh health ministry says that raids have been conducted many times at Katchi Gali, but the agents in this business are so quick that they receive news of the inspection and instantantly shut down their shops.

Government officials and members of the pharma industry agree that the wholesale markets have to be regulated and made to issue a bill of warranty to enable action against people involved in such activities. A bill of warranty is an invoice provided by manufacturers and authorised dealers for the sale of each drug to the purchaser — which is usually the retailer. This poses more of a problem in Sindh, as compared to the other provinces, as it is the only province where no warranty is provided. If wholesalers are forced to issue a warranty, it will allow for legal action to be taken against those who manufacture or sell counterfeit products.

At present, if a complaint or an FIR is lodged against a person or company, unless the entire chain — comprising the manufacturer, authorised dealer, retailer and market — through which the medicine has travelled is identified, the accused cannot be prosecuted if the chain breaks at even one point. And usually, it does break. However, if the medicine is bought from the wholesale market, there is virtually nothing that can be done about it because they give no bill of warranty, thus there is no proof against them. What many government officials and members of the pharma industry suggest to curb the problem of the wholesale markets is that, instead of completely eliminating them — which is virtually impossible — all shops there should be turned into authorised dealers of pharmaceutical companies. That way, they will need to acquire certification for their shops, and will also be under the scrutiny of inspectors and the rule of law.

However, at the same time, the drug courts, too, need to be brought under scrutiny. A clerk at the drug court in Karachi reveals their pitiable state. He says that many tactics are employed to dodge cases and, overall, the judges of the drug court have a very non-serious attitude. They are hired on a three-year contract by the Law and Justice department and, usually, have nothing to do with pharmaceuticals; they may come from banking courts, for instance. “A four-member bench is required for the hearing of a drug case, comprising a judicial member, a technical expert, a medical representative and a doctor. Mostly, at least one of the members is missing,” says the clerk.

He also adds that those who have a case registered against them usually seek to prolong the case, by either not showing up for the hearing or not producing a required document, and if 265 days lapse without arriving at a verdict, the case is discharged. As for out-of-court settlements, these are common, especially where big companies are involved.

While the problem of counterfeit medicines might seem insurmountable, solutions must be sought, and current Chairman PPMA (Pakistan Pharmaceutical Manufacturers’ Association) Kaiser Sajjad proposes to begin with the most obvious one. The first step that can be taken is to put restrictions on the advertisements in the print and electronic media. “If you watch television,” says Sajjad, “there are several advertisements that promote weight-reduction and weight-enhancement pills and doctors offering such services. We wrote to PEMRA and the previous health ministry, but nothing was done about it.”

Secondly, public awareness is absolutely essential in countering this problem. Speaking about a presentation the Pharma Bureau made in collaboration with Toyota in Faisalabad, where they showed people the difference between real products and copies, Riaz Hussain, its executive director, says that this exercise needs to be undertaken on a large scale to educate the public.

“We know that some places, such as Faisalabad and Multan, sell products which are similar to our member companies, in both name and design, but since the people are not very well-educated, they see the external look of the product and purchase it. For instance, there is a medicine to relieve ear pain which shows a king with a sword. People go and ask the shopkeeper to give them the ‘talwar wala badshah.’ So we enlightened them on how products were being copied and the variations that existed in the replicated products.”

The agents in this trade exploit people’s ignorance to their advantage and people need to be made aware on how to detect counterfeit medicines and stop buying them.

However, the government or civil society alone cannot eradicate this problem and both must work in a coordinated manner. According to Talib Lashari, the executive coordinator of The Network for Consumer Protection, attention needs to be paid to the short-term as well as the long-term aspects of the problem. In the short term, the government has a major role to play in devising adequate laws and regulating the markets, companies and people. The private organisations, too, can perform regulatory functions in their own capacity.

As for the long term, he says, “It is necessary to address the people through the print and the electronic media. People need to be educated about the proper and rational use of medicine.”