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Continued from last……
The regulatory landscape has changed rather rapidly, more than it happened at home. It is important to have a look at it.
Two key instruments have seriously impacted the regulatory environment. One is the introduction of CTD dossier and the other is Plant Inspection by Importing country. The primary motive is to discourage import from least regulated countries. And the Primary reason is protectionism. Both may be operating jointly or singly, depending upon the country situation.
When I visited Vietnam in 2005, their reliance on imported medicine was around 80% of country need. They encouraged imports. Registrations (visas) were granted in few months, accepting simple dossiers. In order to facilitate further, one time import license (quota) could also be applied so that the business would start immediately. Several Pakistani companies developed huge business in Vietnam. By 2010 things had started changing and by 2012, it had seriously changed. All Pakistani companies, without exception, have lost all or major part of business. The same treatment was given to Indian companies. New visas were not granted; existing visas were not renewed. Vietnam still does not go for inspection. They Drug Administration Vietnam (DAV) require ACTD dossier which is the Asian version of CTD. The country is very oriented towards Vietnamese companies for generic products. It is a good policy for the country.
Ethiopia had a very small industry of its own in 2005. Several Pakistani companies pursued their regulatory authority DACA to plan inspection of companies. Finally, their panel came here, inspected thirteen plants and rejected all.
During Expo Pakistan 2007, Philippines minister of health visited and had a special session with Pharma companies. He invited the companies to come to Philippines and start business. He promised to facilitate. Currently, Philippines BFAD would want to inspect plant and because they do not have enough inspectors, the dossiers are piling up fast.
Kenya made CTD dossier mandatory over ten years ago; Tanzania followed suite. The list goes on.
Every country has the right to protect its interests. There is no point in criticizing these changes; readiness to get approved should be achieved, both in documentation and cGMP practices.
Pakistan government has not been supportive of Pharmaceutical exports historically. India established PHARMEXCIL (Pharma Export Council) very early on. It provided technical support, financial support and physical support to Indian pharma companies. They took groups of pharma companies to various exhibitions world over. PHARMEXCIL also had their own presence (a stall) in these exhibitions. The Export Promotion Bureau of Pakistan on the contrary, was always more inclined towards textiles, leather goods and surgical goods. EPB working was highly bureaucratic and left much to be desired. During Musharraf regime, EPB was finally converted to Trade Development Authority Pakistan (TDAP). Tariq Ikram was appointed its first chief executive. He was MD of Reckitt & Colman (now Reckitt Benckiser). Because of his professional training, he ran TDAP like a corporate and brought several positive changes. Also, due to his Pharma background, the pharma industry got a new focus for export. Pharmaceutical exports were supported in the following important ways.
- Regular delegations to various regions and countries. Participation was financially subsidized by TDAP
- Payment of salaries of sales teams installed in importing countries
- Financial support for registration expenses
- Financial support for BMR (Balancing, Modernization, Renovation) of manufacturing plants
- Mobilization of Commercial Counselors in Pakistan embassies to promote and facilitate exporters
These steps were highly supportive. As it happens, some companies took real advantage and built their export business further; some only took advantage. After the departure of Tariq Ikram, TDAP largely went back to its old EPB practices.
Tougher regulatory requirements and lack of adequate support has triggered significant negative impact on Pakistan Pharma export causing serious reduction in volume. It is imperative to take corrective measures.
I do see more companies still pursuing international business and making some gains, which is a silver lining.
To be continued……