The move, according to pharma lobby groups could have serious ramifications for the Indian pharma industry, even leading to possible shortages of antibiotics, and anti-diabetes, anti-psychotic and antacid drugs.
In its order, the Central Drug Standards control Organisation (CDSCO) said the active pharmaceutical ingredients (APIs) supplied by these Chinese firms may lead to health risks. Similar orders have been sent out to port offices so that their products don’t enter the country.
APIs are a drug’s central, chemically active ingredients that produce the intended therapeutic effect on a patient. According to CDSCO, India imports about 84% of the APIs it needs. It purchased APIs worth Rs13,853 crore from China in 2015-16, or 65.3% of the Rs21,217 crore total APIs consumed in the country. These included ingredients for essential antibiotics. The rest came from Europe, Japan and the US.
The alert follows an inspection of seven manufacturing units in China that supply the bulk of APIs required by Indian pharma firms. The inspections were carried in November last year, following which DCGI cancelled the import registration of six of these firms. Along with this, DCGI also cancelled around 100 import licences of Indian companies which were buying APIs from these Chinese companies.
According to DCGI, “non-compliances" were observed by the Indian inspection team that visited China.
“Not adequate in process quality control checks, no adequate qualification subsequent to the changes, inadequate re-validation of analytical procedure, registration requirements in contravention to GMP (good manufacturing practices) requirement of schedule M of Drugs and Cosmetics rules were found," DCGI said in a notice sent to the firms. Mint has reviewed a copy of the notice.
DCGI’s regulatory sanctions have triggered concerns about the quality of APIs supplied by these firms to India, one of the biggest markets.
Show cause notices for alleged non-compliances were issued on 26 December to the six companies—Shanghai Xiandai Hasen Pharmaceutical Co. Ltd, Shougang Fukang pharmaceutical Co. Ltd, Qilu Antibiotics Pharmaceutical Co. Ltd, Henan Xinxiang Pharmaceutical Co. Ltd,Zhuhai United Laboratories Co. Ltd and Qingdao Bright Moon Seawood Group Co. Ltd.
Mails seeking response from Zhuhai, Shougang and Qilu remained unanswered till press time. Shanghai Xiandai, Henan Xinxiang and Qingdao Bright Moon could not be contacted immediately.
The order to Indian companies, sent on 5 January, said, “It is observed that manufacturing facilities registered with this directorate are not complying with GMP requirements specified under schedule M as per the provisions of Drugs and Cosmetics Act 1940 and rules 1945. The medicinal products with these APIs may lead to risk human consumption. You are hereby ordered to stop the import of the drugs registered under the registration certificate with immediate effect till a satisfactory response is submitted against the show cause notice issued." The order has been reviewed by Mint.
The GMP violations and the ban on the plants underscore growing concerns about the quality of medicines made in India, DCGI said.
“Companies will have to pull up their quality parameters to continue work with India. The imports from these companies will not be allowed till the time we are satisfied. We have to make it clear that quality cannot be compromised and we can’t put Indian population at risk due to poor quality products," G.N. Singh, India’s drug controller general said.
People aware of the matter said the decision to audit Chinese drug manufacturing units was taken after several import licences of local agents were cancelled due to poor drug quality and their failure to comply with GMP.
“This was the second such major inspection carried by CDSCO experts after the first inspection in 2011," added Singh.
While India’s regulator may have turned on the heat on Chinese drug firms, pharma lobby groups expressed concern, saying the trend of stepped-up enforcement in one of the largest markets for API manufacturing may lead to a shortage of drugs in India, especially third line antibiotics, which in turn could take up their prices.
The companies in China manufacture APIs such as Potassium Clavulanate, which is an antibiotic useful for the treatment of a number of bacterial infections; Metformin, which is used to control blood sugar levels; and Mannitol, a type of sugar alcohol, which is also used as a medication.
“Many of these items are manufactured by only a few companies. Banning them from entering the country will accelerate the prices. Many of these firms are complying with US standards. The action by India’s drug regulators is therefore questionable," said an expert on the sector requesting anonymity.
Officials in CDSCO though say alternative products are available and there won’t be any shortage. “All penicillins come from China, but we don’t see any shortage to an immediate effect," said one of the officials on condition of anonymity.