'Fruitful R&D initiatives vital'

By Sanjeevi JAYASURIYA

The local pharmaceutical industry continues to grow and with regulations in place it could be a vibrant sector contributing to the economy, Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) President Vish Govindasamy told Sunday Observer Business. However, fruitful research and development initiatives are necessary to improve the current status of the industry, he said.

Excerpts of the interview.

Q. As an Industry what is the progress it has made so far?

A. Starting from home remedies to 'corner drug store' where decoctions and carminative mixtures were sold by pharmacists, the industry has made great strides in research and development of new chemical entities. Life expectancy has increased to seventies and eighties in many countries, inspite of the increase in air pollution and poor sanitation, mainly due to the treatment options and choices provided by the industry which has dedicated itself to research and development.

In the initial stages, like in any developing industry there were excesses over the years, which resulted in a highly regulated industry where the patients' welfare became the main focus.

With the introduction of the compliance law, the pharmaceutical industry has become one of the most regulated industries in the world. It will take a few years for this benefit to be fully available in developing countries due to the large generic manufacturing base, however with Asian manufacturers entering the European and USA markets they will be compelled to follow these regulations and we will have the opportunity to enjoy the protection of compliance even in Asia. SLCPI has already initiated a code of ethics which regulates the local industry.

Overall the pharmaceutical industry which is regulated by the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations), is now regarded with respect in the West for their innovation and commitment to be in line with ethical guidelines of the healthcare industry.

In Sri Lanka, after the SLCPI was set up, we have worked with the Ministry of Health in a cordial manner. We have participated in all deliberations at improving procedure to streamline delivery of healthcare in relation to pharmaceuticals.

We were members of the NMDP (National Medicinal Drugs Policy) Steering Committee and continue to be in the Technical Advisory Committee of Ministry of Health (MoH) which makes policy decisions. SLCPI officials participated in many regular and emergency forums as and when the need arose.

From a handful of importers, the industry has progressed to accommodate over 100 importers and market both original, branded generics and generic pharmaceuticals of Sri Lanka. The private sector can boast of a continuous supply of quality pharmaceuticals at low cost, contrary to popular belief and anti pharma propaganda. The WHO and Health Action International in their findings demonstrate that pharmaceutical pricing in Sri Lanka is low and in many instances lower than that in India giving prescribers and patients a healthy choice.

Q. What are the drawbacks for the industry's development?

A. In Sri Lanka, we are proud of the progress made by the Ministry of Health. At the initial stage, all approvals for pharmaceutical imports was the decision of one or two individuals and for the past 30 years or more a definite progressive development had taken place to ensure quality, efficacy and safety is accounted for in all the imports to the country.

However much officials try to accommodate the work load of a growing economy, they are not provided with adequate resources to meet the increasing demand, which is the result of several approvals being needed prior to importing pharmaceuticals.

The industry has discussed ways and means of reducing the workload by eliminating duplication and we have had a good response from the MoH and CDDA.

However, a lot more can be achieved together to ensure less occasions of stock outs and a smooth flow of quality medicine to the country.

We also need to study the role of the local industry and pay more attention to their grievances. If other Asian countries can export pharmaceuticals, we also should be able to do so or at least attract foreign principles to set up factories to service Asia.

India with all the labour unrest and the escalation of cost is fast becoming an expensive destination to locate factories.

The constant negativity and 'industry bashing' that has taken place over the decades and the ban on medical representatives entering government hospitals has sent wrong signals to potential investors.

Not only have these factors kept away investors, a number of research-based companies (i.e. Pfizer, Park-Davis) that had local manufacturing facilities have sold out their facility and have left the country altogether or have downgraded their presence in Sri Lanka to mere agency operations.

The fact that the Universities of Sri Lanka did not offer a Pharmacy Degree until recently, has also hampered the development of the local industry as a pool of local expertise was lacking.

Q. In what areas is the industry lagging behind?

A. A new chemical entity takes a long time to register. Sometimes our patients need to wait a long time to get the benefit of new research. One can argue and say "let all the countries in the West try and we can then import". However, from a patient's point of view if one has a terminal illness and the remedy could prolong life for another six months to one year, it is a life-time to the patient and the relatives. We are allowed to get these on a user license which is costly. A fast track method needs to be adopted for life savers.

We definitely need a knowledgeable team of healthcare professionals who can assess the humanitarian needs of the patients and to facilitate faster response. They also can regularly meet SLCPI officials to discuss and facilitate the reduction of bottlenecks which cause delay and unproductive time to the MOH and industry.

The industry has also failed to effectively self-regulate itself and live up to the expectations of the public in terms of ethical behaviour when it comes to its relationship with the medical profession.

Q. What is the way forward and suggestions for improvement?

A. Like in other developed and developing countries, consultation with the industry body prior to making drastic changes is a must to avoid unnecessary wastage of time and effort.

Streamlining the procurement process of the Government to ensure adequate time is given for imports and planning to ensure availability. We need to improve the lead time between a request for an order and the time an order is placed, which is done mostly on a need basis now. Since pharmaceuticals need adequate production, the procurement process time to manufacture must be spaced out, we must respect each other's constraints.

A regular update with the media to ensure we take the message to the public without major deviations is also a must. People need to know the truth about the industry and the services it provides rather than negative reports generated without proper research.

Health is the most important aspect of a country, the best healthcare professionals who understand the need, gravity and the enormity of each aspect thoroughly, need to be appointed to key positions.

We observe that when one is getting accustomed to the operation, he or she is transferred and we have to start all over with a new official.

Succession planning and continuity is of paramount importance. A regular and proper dialogue will result in a better understanding for the industry with government officials and the media.