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DCGI seeks action taken report from Bihar DC on delaying licensing process for sanitizer manufacturing in the state
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Peethaambaran Kunnathoor, Chennai
August 01 , 2020
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The Drugs Controller General of India (DCGI), Dr V G Somani, has sought an action taken report from Bihar state drugs controller Ravindra Kumar Sinha on a complaint by the Indian Drugs Manufacturers’ Association (IDMA) against him for failing to issue licences to the drug manufacturers in Bihar for manufacturing hand-sanitizers during this COVID-19 period.
However, when Pharmabiz asked about the DCGI’s letter seeking an action taken report from him on the matter, Sinha said he did not get any letter in this regard.
Earlier, the IDMA had written a letter to the DCGI seeking his immediate intervention in the matter. According to IDMA, the state drugs controller, Ravindra Sinha was deliberately delaying the licensing process and did not issue manufacturing licences for hand-sanitizers within three days of the applications received.
The national drug manufactures’ association, IDMA, was approached by the Bihar Drugs and Pharmaceutical Manufacturers Association (BDPMA) after a long period of request to the state health ministry and to the offices of the principal secretary. Since all the attempts of the manufacturers in getting licences from the licensing authority failed, they approached the High Court of Patna for a direction to the DC.
DCGI, the national drug regulator, has in his letter to the state DC wanted him to send a report of the actions he has taken in the complaint of the manufacturers and intimate him the reasons for the delay occurred in issuing the licences. As per government order, issuance of licences and approval for hand-sanitizers and face masks should not be delayed during this COVID period. But despite repeated requests from the manufacturers association, the licensing authority did not issue licences to the applicants. Consequently, some of the entrepreneurs had to approach the High Court in the month of June.
BDPMA is alleging that the DC of Bihar, Ravindra Kumar Sinha, is deliberately delaying the process of issuing manufacturing licences. This unethical action of the DC has impacted the pharmaceutical manufacturing sector of Bihar as distributors of the state were forced to purchase products from other states to sell in the market on high prices. The poor people of the state are suffering a lot because of the high prices of the imported products. The association wanted the government to take legal action against the drugs controller for his continuous unethical activities which are badly affecting the poor people of the state.
According to Sanjiv Rai, president of the BDPMA, the drug market in Bihar is now flooded with sanitizers manufactured in other states, and they are sold at high MRP. He said the domestic manufacturers could be able to produce and sell the same quantity of bottles at a less price had the state drugs controller issued manufacturing licences on time to the applicants.
He said, in the month of March, 10 manufacturers applied for licence, but the DC office did not issue the licences, consequently five units have approached the High Court for direction to the DC to expedite the process of licensing. As a result, five manufacturers received the licence. It is alleged that even during the lockdown period, Ravindra Sinha had ordered for site inspection before issuing licence, and drug inspectors visited the sites and submitted reports to the DC on 28th March. Even then, the DC did not issue the licence till the HC intervened, and that too only for five people who approached the court.
When Pharmabiz contacted the new principal health secretary, Pratyaya Amrit, he said he joined the department very recently and will look into the matter.
Sanjiv Rai, president of the BDPMA, said the drug manufacturers of Bihar fully trust on the new principal health secretary for maximum support for the domestic pharma manufacturing sector. He expressed the hope that the new bureaucrat will set right all the issues that the drug manufacturers face due to the state drugs controller for a long time.
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