Duty exemption withdrawal on drugs to boost Make in India:Govt

Centre's move to withdraw customs duty exemption on imports of over 70 drugs, including life- saving ones used for treating cancer and HIV, is in line with the Make in India programme, as the government claims it will boost domestic manufacturing, Parliament was informed today.
"The above action of the government to withdraw exemption also contributes to the Make in India strategy," Minister of State for Chemicals and Fertilisers Hansraj Gangaram Ahir said in a written reply to the Rajya Sabha.
Earlier this month, the government had withdrawn customs duty exemptions on 74 drugs, including life saving ones used for treating cancer and HIV.

But within few days, in the face of criticism from various quarters, the government had restored exemption on three of these 74 drugs drugs that are mainly used for treatment of hormonal disorders, growth failure and haemophilia.
The move to withdraw customs duty exemptions was criticised as it would lead to a rise in prices of essential medicines.
The government had defended it saying drugs removed from exemption list were capable of being produced in India and such a move would promote domestic manufacturing.

The medicines on which customs duty was imposed included the ones used for treating kidney stones, cancer chemotherapy and radiotherapy, life-threatening heart rhythm disorders, diabetes, Parkinsons disease, bone diseases and antibiotic to treat infections.

Replying to another question, Nadda said many State
Licensing Authorities (SLAs) had, despite not having the authority to grant licences for new FDCs, continued to grant licences without approval of the Drugs Controller General (IndiaDCG(I).
Nadda said the Department Related Parliamentary Standing Committee (PSC) on Health Ministry had observed that some SLAs had issued manufacturing licences to a very large number of fixed dose combinations without prior clearance from CDSCO which had resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety.
"DCG(I) had requested all state and UT Drug Controllers to ask the concerned manufacturers to prove the safety and efficacy of such FDCs as had been licensed by SLAs prior to October 1, 2012 without obtaining the approval of DCG(I).

"In reply, CDSCO received approximately 6320 applications from manufacturers for proving the safety and efficacy of these FDCs. On scrutiny, it was observed that many FDCs are being manufactured by a number of applicants," Nadda said.
He said a ten-member expert committee was then constituted in 2014 for examining the safety and efficacy of these FDCs.
"The expert committee, after detailed examination and deliberations recommended that some of these FDCs that lacked therapeutic justification, were found to be pharmacokinetically or pharmacodynamically incompatible, had abuse potential or could lead to antibiotic resistance in the population.
"After careful consideration of the matter, the government issued show cause notices to all the manufacturers whose products were found to be irrational and who had submitted their applications to the Central Drugs Standard Control Organization.

At the request of the manufacturers, additional time of three months was given to them to respond to the show cause notices. Thereafter, after due consideration of the report and replies, the government on March 10 this year prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs with immediate effect in public interest, Nadda said.