Along time, many different kinds of surgical and medical devices and tools have been invented, some of them of a more general character, others designed for a specific type of surgery.
Then what is a drug? And what is the requirement of being named as a drug? If we look into different dictionaries we find the exact meaning of a drug. For instance according to Dorland’s Medical Dictionary, “Any chemical compound that may be used on or administered to humans or animals as an aid in the diagnosis, treatment or prevention of disease or other abnormal condition, for the relief of pain or suffering or to control or improve any physiologic or pathological condition”.
The definition pertaining to chemistry is “a substance composed of chemical elements or obtained by chemical processes”. According to the notification, there is no difference and line of demarcation seen between drugs and surgical and medical devices, and if we get into the details both these things lie under two different categories and their procedure of registration also should be different. Both are supposed to be registered differently. There is a complete different set of principles for drug registration and a completely different one for the surgical Instruments/medical devices at US-FDA, too!
If we look at the procedures of registering drugs we see that it takes almost two to three years in the registration of a drug and almost a million rupees are spent on the registration of a single drug. Drug authorities and drug inspectors are supposed to regulate it and deal with the registration. We cannot afford to register surgical and medical devices as drugs and there is simply no need for doing that. Reason being that most of the companies working in Pakistan and manufacturing or importing surgical and medical devices have relevant ISO certifications. This certification and affiliation is more than enough to proof its credibility, reliability and trustworthiness. The US-FDA, too, only requires relevant ISO certifications to register surgical equipment and disposables. Drug inspectors legally and professionally should have nothing at all to do with the inspection, regulation and registration of surgical and medical devices. It is altogether a different ballgame!
In Pakistan if the SRO prevails then there are going to be a lot of after-effects. We are already witnessing the repercussions. Due to this notification given by the federal government the local industry of surgical and medical devices is going to be affected badly and will collapse as the local industrialist will never be able to spend millions for the registration. The rates are going to be extremely high, almost out of range for a common Pakistani, and not many companies will take the initiative of getting registered each and every medical and surgical instrument.
The rates are going to touch the skies and there is going to be a terrible shortage of the medical instruments. Only a few giants will monopolize the industry and the bureaucratic hassles will either make several medium and small size importers to quit or to restrict their businesses to only those highly profitable products which they could afford to register with the drug authorities. At the end of the day the only ones who are going to be the sufferers will be the poor patients.
In the SRO certain meanings are not clear at all, and they badly need clarity as these are creating problems for the stockiest. There is lifting of goods from the shops, which is creating problems and in future may create an acute shortage of life-saving medical devices due to which the patients all over Pakistan are facing difficulties in the treatment of their ailments.
In the said SRO, the word/items such as canula, catheter and stent are used and if we see there are more than 100 types of catheters in use with different utilization. For ready reference, the term catheter is used for intravenous catheter and intra-urinary catheter. It is made up of complex latex material and is used for urine drainage, while this term is also used in medical profession for anything which may be inserted into the human body like central venous pressure line is called catheter.
Similar is the case of stent. Where-ever an obstruction is observed in a human body, health practitioners bypass the obstruction with a stent and there are several stents in use for the treatment. Some are made of synthetic woven material and some are made of metals.
On the other hand, strangely enough the needle alone is not brought under registration which is the main source if someone gets pricked. Spinal needle is majorly used to collect spinal fluids from the lumber vertebrae, and a special basic necessity for critical care/ICU patients. Needles are the products which have their own brand name, which are imported in Pakistan without any check and balance.
To conclude, there is going to be turmoil, ailment, agitation and anxiety if all the surgical and medical devices are going to be registered as drugs. It’s high time that the federal government altered and took back the decision as it was going to bring a mountain of problems with its application and it’s time to realize that there is nothing more important than people’s lives. The mental anxiety that people are going through this decision is far greater even than their physical disability, pain and requirement.
A government exists to protect the rights of common citizens. Good governance protects human security by maintaining law and order, delivering justice, conflict management, safeguarding the property rights of ordinary people and most of all giving them access to affordable health facilities.
The MoH should review this decision by withdrawing the SRO and developing a separate regulatory regime for the medical devices and surgical equipment in consultation with the stakeholders for the benefit of the patients and people of Pakistan. The drug control authorities should not and cannot be given regulatory responsibilities over the manufacturing and import of medical devices and surgical equipment.