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Expressing its disappointment and disapproval over the proposal of the Union health ministry for hiking licence fees for manufacturing companies, fees for registration of domestically manufactured new products, registration/licence for importing medicines, registration of imported products in the country and for conducting clinical trials, the Indian Drugs Manufacturers Association (IDMA) has appealed to the government to reconsider its plan to increase the fees.
However, the association gave its green signal to the government, in one case, to go ahead with the hike in the registration fee for import of pharmaceutical products. IDMA has sent a representation to the government of India with respect to this issue.
The proposal of the government came out through the Drug Controller General of India (DCGI) last month as draft rules. Approval of the draft rules will enable the national regulator to put them as amendments in the fee structures of the Drugs and Cosmetics Rules, 1945.
As per the draft rule, the fees for domestic manufacturing and loan licence will go up to 50,000 from the existing amount of 6,000. Charge for site inspection will increase to 15,000 from 1500 now.
Fee for site registration for importing medicines is likely to be raised to 10,000 USD from the existing 1500 USD. Registration fee for imported medicines will go up to 5000 USD from 1000 USD. Further, the increase in fees proposed for registration of locally manufactured products is 2,50,000 from the existing fees of 50,000.
Responding to questions from Pharmabiz, S V Veeramani, president of IDMA said, “We disapprove this fee hike for the domestic and export markets since it will burden the industry, particularly the SMEs, and can result in increase in drug prices in the domestic market. As exporters are having licences for several products in order to tap the international market, their cost will also go up”.
He further said considering the hike in import registration fees, it is acceptable as it will protect the local industry.
Pointing out to the present situation of the pharma industry, Veeramani said, the small scale industry is already reeling under hardships like the need for upgradation of plants, denial of adequate opportunities in government tenders, high rate of interest and difficulty in getting and retaining technically qualified personnel. Under these circumstances, a hike in licence fees will further burden them and make things difficult for them.
Despite the proposal of the government likely to affect the industry adversely, IDMA has full confidence in the Union government owing to the industrial and business development initiatives, such as ‘Make in India, ‘Ease of doing Business’, Encouragement to Start-up units’ etc, being introduced by Prime Minister Narendra Modi. Veeramani expressed the hope that Modi government will not hold a decision or project against the growth of domestic industrial units and his government will reconsider the decision to hike the fees.
As regards the fees hike, the DCGI last month issued the draft rule inviting suggestions from the stakeholders. The proposal also increases the fee for licences for drugs sales as well as for conducting clinical trials.
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