India has banned the import of a rabies vaccine from the Chinese manufacturer Changchun Changsheng Bio-technology, the head of India’s drug regulator told a newspaper in comments published Wednesday.
“The vaccine is being used in India, but we don’t have the exact details of the total number of units imported or where they have been distributed,” S Eswara Reddy told the Hindustan Times.
“I have asked my staff to prepare a detailed information report on its import and distribution,” he was quoted as saying in the interview. “Once we get the information, we will ask for a recall of the vaccine from market. But until then, there is a blanket ban on its import.”
The firm was earlier found to have falsified data and sold ineffective vaccines by Chinese authorities. It also fabricated production and inspection records relating to a rabies vaccine used for infants.
The scandal has shaken Chinese public’s confidence in domestic-made drugs and medical products.
Rabies kills an estimated 20,000 people in India every year, according to the government’s National Rabies Control Programme.
At the cabinet meeting Monday, Chinese Premier Li Keqiang instructed government departments to supervise exporters to recall Changsheng vaccines sold to foreign countries, as well as to provide timely update to the World Health Organisation and concerned governments.
Meanwhile, China’s State Drug Administration (SDA) said Wednesday an inter-agency auditing task force, including the drug regulator and the National Health Commission, has been dispatched to the central China city of Wuhan to audit another vaccine maker’s ineffective DPT vaccines manufactured last year.
On Tuesday the SDA published details of its investigation into Wuhan Institute of Biological Products which, along with Changsheng, was found to be producing inferior vaccines in November 2017.
The regulator said on its website the cause of Wuhan’s substandard vaccines was accidental because its packaging equipment had experienced a temporary malfunction that caused ingredients in the vaccine to be unevenly distributed.
The company recalled and destroyed all 400,520 inferior vaccine doses on May 4 and was also fined an unspecified amount, the regulator said.
It said Wuhan was considered to have fixed its production issues after passing inspections in March.
The inter-agency task force is led by SDA deputy chief and Communist Party committee secretary Li Li.
A special cabinet investigation team said on Friday Changsheng had systematically falsified production and testing records to avoid regulatory scrutiny, and had also sold 252,600 doses of ineffective DPT vaccines to inoculate children against diphtheria, whooping cough and tetanus.
China has already ordered the arrest of 18 people at Changsheng, including its chairwoman Gao Junfang.
The State Council also called for a full investigation into any potential regulatory failings, including possible dereliction of duty by officials, and said a long-term mechanism should be established to ensure public safety.