Complaints Lodged Against Bihar DC For Delaying Licences For Manufacturing Hand Sanitizers

Chennai, 9 June 2020:

In spite of all possible measures taken by the health department of Bihar to contain the outbreak of COVID-19 pandemic and maintain availability of all essential drugs during the present crisis period, the state pharma industry alleges that all the healthcare efforts of the state government is torpedoed by the state drugs controller by deliberately delaying licensing processes and resorting to illegal actions.

Even for licence for hand sanitizer manufacturing, the industry has to approach the High Court to direct the DC to grant permission.

The complaint to the government says that even during the COVID-19 period, the state drugs controller is holding up the applications for licences for manufacturing hand sanitizers, alleges Bihar Drugs and Pharmaceutical Manufacturers Association (BDPMA).

Expressing dissatisfaction over the way the drugs controller is acting, the state pharma manufacturers have lodged complaints with the chief minister, health minister, industry minister and the chief secretary against the DC and urged them to intervene in the matter and speed up licensing processes for manufacture of all essential drugs, hand sanitizers and face masks in adequate quantity. BDPMA further wanted the government to conduct an enquiry on how the drugs controller is dealing with drugs laws and with the pharmaceutical manufacturing sector.

“As on today, out of the 427 applicants only 12 people received manufacturing licences for production of hand sanitizers from the DC department although the central government has directed all state SLAs to issue manufacturing licences for sanitizers without any delay. Out of the 12, two applicants received licences for ethanol based sanitizer only after one month of submitting applications and finally they had to approach the Patna High Court for a direction to the DC to issue licence. The remaining 10 licencees are manufacturing IPA (isopropyl alcohol) based product”, said an office-bearer of the BDPMA in anonymity.

When contacted the Tamil Nadu drugs controller Sivabalan said he has issued 138 manufacturing licences for hand sanitizers within one week time. The DC of Kerala said he granted permission to 45 manufacturers to produce hand sanitizer in the lockdown period.

Bihar Drugs and Pharmaceutical Manufacturers Association, the lone association of pharma industry in the state has informed the government that the drugs controller, Ravindra Sinha is acting against the law of the land with regards to pharmaceutical manufacturing. According to sources from the regulatory officers association, this is the first time in the country, an industry association of a state is approaching the government raising complaints against a state drugs controller. Last year, BDPMA had lodged a complaint with the DCGI office in New Delhi against Ravidnra Sinha alleging that he was overruling CDSCO’s guidelines and directives.

The drugs controller is violating all the drug laws at a time when there is direction from the central government to state drugs controllers that licence for producing the safety product, hand sanitizer, should be issued as early as possible as the health of the people is the main concern. The national drugs regulator (DCGI), in his letter dated 17.03.2020 directed all state drugs control authorities not to make any delay in issuing licences for manufacturing sanitizers in the wake of spread of coronavirus disease. But the DC of Bihar is not complying with the direction of the central government and guidelines of the World Health Organization, it is alleged.

According to industry sources, the government is not interfering in the affairs of the drugs control department, so the DC is acting according to his whims and fancies.

When Pharmabiz contacted the health minister, Mangal Pande, he refused to respond to queries pertaining to the activities of the drugs controller. Although Pharmabiz repeatedly tried to get in touch with the new health secretary, all attempts have failed. Pharmabiz