May 15, 2006	Monday	Rabi-us-Sani 16, 1427

GIVE a Japanese or a German car to a mechanic in Bilal Ganj (Lahore), he will tear it apart into thousands of pieces and join it back into a perfect condition like a jigsaw puzzle, some times even better than the original. But ask him to invent his own car with a unique design- he might struggle.

A general lack of innovative culture and reliance on foreign technology is prevalent in every sphere of life and business. There are more than 350 national and almost 40 multinational pharmaceutical companies operating in Pakistan to fulfil the healthcare requirements of 160 million people.

The backbone of any industry and its long term sustenance lies in research and development (R&D). Ironically, like the rest of the industries, our pharmaceutical industry—both local and foreign companies— does not indulge in any innovative R&D activities.

The senior Pakistani executives in multinational companies (mostly of Pakistani origin) hardly make any effort to sell Pakistan’s potentials at their companies’ global or regional forums.

The health ministry also runs on ad hocism. Projects and plans are person specific and tend to die out as soon as the previous secretaries, director general or the drugs controller move on or are replaced.

New drugs still get registered in Pakistan only because they are registered in developed countries. We don’t have any scientific committees to review the pre-clinical or clinical data that makes the basis of a drug registration process. Our ministry has a drug registration board and an appellate board: both of them are mainly concerned with the cost of the drug and hardly ever go into a scientific discussion on the safety, tolerability, pharmacokinetic and pharmacodynamic capability of the drug under consideration.

Drug discovery apart, our health ministry no longer asks for bio availability or bio-equivalence trials for generic medicines (which is a global standard requirement for generic drug registration). The ministry also does not recognise any local institute to be capable of running these studies to show mere bio-equivalence to the branded drugs. If one queries the authorities on the reason for not even matching up with Indian standards, the answer is point blank, not possible; we are far behind and cannot catch them.

Multinational pharmaceuticals spend substantial amount on R&D. Because of the growing need for new and innovative medicines and the rising cost of drug development, most MNC’s have started moving their R&D bases to offshore sites like Singapore, South Africa, China and now India. The Pharma R&D sector is one the fasted growing industries in Asia, with India getting the major share after its implementation of TRIPS obligations.

There was a time (only six years ago) when no multinational would even think about going to India for any R&D activities and at the same time they were willing to freely involve the MNC’s in Pakistan to take up the South East Asia’s share of global R&D spending. But due to various concerns, Pakistan is not a destination for such investments.

India presents immense opportunities to multinational pharmaceutical industry. The rising cost of drug development and increasing pressures on regulations in the western world have played an important role in shifting R&D bases of major pharma players to India.

Only the US pharma industry outsourcing business is predicted to grow to $48 billion by 2008, and Indian companies are targeting at a major chunk of this pie. The clinical research services revenue for India is estimated to rise from a $35 million in 2002 to $300 million in 2010.

Indian government (ministry of health, finance, taxation, revenue, IT and labour) is making every effort to meet the regulatory and ethical requirements to facilitate R&D and clinical trial industry. Measures have been put in place to ensure implementation of Good Clinical Practice guidelines.

These measures have jointly been put in place by (DCGI) Indian drugs controllers’ generals office, Indian council of medical research (ICMR) and Biotechnology department (DBT). These laws and processes facilitate not only their local R&D pharma base but also the multinationals to meet international standards.

Large pharmaceutical companies are still looking for effective ways to meet their growing needs and prefer outsourcing R&D and IT services to low-cost, high output countries and Pakistan can still be a major player in this game. With a slight orientation in our mindset, we can bring a change whereby local companies can go into alliances with international companies willing to do contractual outsourcing arrangements and establishing local subsidiaries to utilize our strong intellectual potential in Pakistan.

Not long ago, some multinational companies were running early phase drug development clinical research in Pakistan. The ministry of health was also in the process of developing guidelines and regulations to implement international GCP guidelines, patient safety and adverse event reporting processes and an SRO was issued by the ministry of health in this regards in September 2001 to establish a national committee on good clinical practices (GCP) and good prescribing practices.

A draft Pakistan GCP guideline document was also developed and probably sent to WHO (world health organization) representative in Pakistan for review and approval. A series of national level seminars and conferences were arranged by the ministry of health to address these issues with medical professional and pharmaceutical industry. There is no formal regulation or written national policy that could be considered as a permanent commitment on part of the government.

Looking at the global trends, India may become the main hub for drug discovery and pharmaceutical development. Then, not only will our national companies be fully dependant on India to obtain the generics but our multinationals will be just mini-outlets of the main multinational hubs in India.

If Pakistan does not jump on this boat now, it will be too late in another year or two.

The writer is a pharmaceutical development consultant