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The Department of Pharmaceuticals (DoP)'s decision to exempt patented orphan and innovative drugs developed by foreign drug companies from price control for five years has received positive response from patent experts.
It will improve accessibility, especially of drugs for treating orphan diseases in the country, they added.
It is estimated that one in 20 Indians is affected by one of the 7,000 diseases listed as rare diseases viz. haemophilia, thalassemia, sickle-cell anaemia and primary immuno deficiency, auto-immune diseases, Lysosomal storage disorders such as Pompe disease, Hirschsprung disease, Gaucher’s disease, Cystic Fibrosis, Hemangiomas and various forms of muscular dystrophies.
The amendments as proposed in the order of DoP dated January 3 is only intended to increase accessibility, especially of drugs for treating orphan diseases etc. In the short term (5 years) affordability may be hit, unless alternate medicines are put in place. However, accessibility and affordability will improve substantially after 5 years, said patent expert Dr. Gopakumar G. Nair.
On January 3, 2019 DoP amended the Drugs (Price Control) Order (DPCO), 2013 to exempt new patented drugs and orphan drugs from price control for five years from the date of commencement of its commercial marketing by the manufacturer. Prior to this amendment in Para 32 of DPCO, exemption for five years was available to only those new drugs which were patented in India but were not produced elsewhere and were developed through indigenous research & development.
With the recent amendment in DPCO, any new drug can get exemption if it is patented in India under Indian Patents Act, 1970 and developed and manufactured by any patentee across the globe. This may provide impetus to licensing in of new medicines amongst the drug companies in India.
If the original DPCO 2013 is read with the order dated January 3, 2019, the changes are minimal. Most of Para 32 remains as such. Para 32 gives the power to NPPA to exempt certain class of drugs from price control.
DoP's move has pitched it against Union health and family welfare ministry which had last week asked it to look into feasibility of regulating prices of orphan drugs to make them affordable to patients. It is learnt that the health ministry had also written to the department of industrial policy and promotion (DIPP) urging it to look into options of putting orphan medicines under compulsory licensing (CL).
The option of CL is non-existent. The health ministry cannot issue CL. In the past also such moves have failed. Grant of CL is only by Controller General of Patents. No CL applications are coming up. Government is not in favour of grant of CL. CL is not an option for orphan drugs as the economic viability will dissuade CL applicants, said Dr Nair.
‘Orphan drugs’ are very expensive, as noted in the National Policy for Treatment of Rare Diseases (NPTRD), 2017. With the number of people suffering from rare diseases is very low, the drug firms find it nonviable to manufacture and market them.
Expressing reservation over exemption from price control for patented drugs first marketing in India, Dr Nair said “The exemption from price control for patented drugs should have been from the date of first marketing anywhere in the world, instead of date of first marketing in India. This could have motivated the new drug patent owner to launch in India simultaneously. As of now, there is no incentive for early launch of internationally patented drug in India.”
Echoing his view, Anay Shukla, who leads pharma and healthcare practice at the law firm Nishith Desai Associates, said “The policy change to extend price control exemption to all patented new drugs should certainly push both domestic and multinational companies to consider India as an important and viable market for high end research based medicines.”
“Unfortunately, there are inconsistencies in the language of the amendment that will make its implementation difficult for the government and the industry,” he stated.
“It is also surprising that the government has not extended the same exemption to innovative patented medical devices which are notified as drugs and, therefore, are subject to price control,” he opined.
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