According to a suggestion by the government of India, price control and procurement plans will tilt those drugs that contain locally manufactured bulk drugs, a proposal to reduce India's exposure to imported raw materials and intermediates Degree of dependence.
Specific area dependency
Up to 80% ~ 90%
In late August, the Indian Medicines Agency (DoP) issued a 'Draft Pharmaceutical Policy' (DPP) and explained that the purpose of the draft is to reduce India's reliance on imported APIs and to address the issue of India's drug Quality concerns.
One of the major areas of concern, DoP wrote in the draft, is that the raw materials and intermediates that Indian manufacturers need to manufacture their medicines are highly dependent on imports from one or two countries, a dependency that is directly linked to Drug safety throughout India.
The author of the draft considered that the production of APIs in India was affected by the introduction of legislation on drug pricing in the mid-1990s (in particular, the Drug Price Control Order was introduced in 1995 and updated in 2013), because these legal Regulations Promote drug producers from other parts of the world purchase Cheap, low quality raw materials to maintain their profitability.
Today, more than 60% of APIs in India come from other countries, and this dependence is as high as 80% -90% for some specific APIs. As for the intermediate phase before APIs and key raw materials (KSMs) This situation is even more serious, KSM is the basic unit of the drug.
Therefore, the draft said India's competitiveness and ability to produce certain APIs are also deteriorating. New medicine The policy needs to address the ways and means to revitalize the production capacity of APIs, KSM and other intermediates in India.
Develop differentiated price caps
In order to address the dependence on imported products and revitalize the production of local APIs and intermediates, DoP said the government should prioritize those medicines that contain APIs from India when formulating drug purchasing plans.
DoP recommends that these products be exempted from price caps for up to five years and that their prices can be linked to what percentage of the 'indigenous materials' come together. "It added that the World Trade Organization's recognized' The principle of "rules of origin" may be used to establish a differential price ceiling (according to the proportion of locally manufactured bulk drugs).
DoP noted that fees charged to importers and producers should be reasonably high to enable them to meet the international standards followed by regulatory authorities in major drug-producing countries standard In addition, all APIs that can be manufactured in India should be subject to the highest tariffs if they are imported from abroad.
DoP also believes that Indian APIs and intermediates producers will benefit from the establishment of a "large APIs Industrial Park," where manufacturers can share pollution control and water treatment facilities and, through relevant departments, including Ministry of Environmental Protection) to the large industrial park officials stationed representatives, several departments together offices, this one-stop service should be able to provide services for the park's factory facilities.
