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Complimenting the Central Drugs Standard Control Organisation’s (CDSCO) drive to seize illegally imported bulk drugs from China weighing 2,354 kg at Chennai recently, the pharmaceutical industry has urged the country’s apex drug regulatory body to retrieve the active pharmaceutical ingredients or their finished formulation sold in the domestic market over the last year to protect citizens’ health.
It is learnt that Chennai-based Kawarlal & Co and Nutranol Ingredients who had imported APIs from China without registration certificate and import license had already sold APIs worth Rs.400 crore in the domestic market. The importers have an annual turnover of around Rs.800.
CDSCO should take prompt step to retrieve the Chinese bulk drugs sold to formulation manufacturers in the country by Chennai based importers illegally as it might be spurious, said representatives of drug industry.
Import of unregistered drugs without quality evaluation is a major health hazard to the patients using formulation made from these bulk drugs, said a drug maker on condition of anonymity.
During registration of the drug for import, quality related information such as the manufacturing process, validation data, analytical procedure, bioequivalence data, stability data, certificate of analysis, etc are evaluated. In the absence of evaluation of aforesaid data the products may pose a risk to public health, he said.
The seizure was made after Chronicle Pharmabiz carried a news highlighting low-cost Chinese APIs thronging Indian market illegally, posing health risk to people on April 18, 2019.
A raid was conducted at Kawarlal &Co, Madhavaram, Chennai by drug inspectors of CDSCO-HQ, New Delhi and South Zone along with drug inspectors of drugs control department, Tamil Nadu on April 25, 2019. During the search at the aforesaid premises, various drugs, erythromycin stearate (235 kgs), verapamil hydrochloride (155 kgs), megestrol acetate (70 kgs), trimetazidine dihydrochloride (1,344 kgs), folic acid (125 kgs), silymarin (175 kgs), calcium D pantothenate (250 kgs) have been found in large quantities.
As per the labels on the containers, all these drugs have been manufactured in China. The names of the manufacturers claimed on the labels are Zhejiang Medicines & Health Products, Ningbo Hitech Biochemicals Co. Ltd., Jingjing Pharmaceuticals co ltd., Shandong Sinder Technology Co., Ltd., etc. It was observed that these bulk drugs are sold to formulation manufacturers as if they are registered by the competent authority. Further, some of the labels also claim that the drug meets pharmacopoeial specification. All the imported bulk drugs which were found stocked without purchase bills.
The cost of the seized material is estimated to be about Rs.1.5 crore, which may be much more in the open market. It is suspected that the total value of illegal transactions may run into several crores.
It is suspected that some of these bulk drugs have been imported illegally from unregistered manufacturing facilities in China. It is also suspected that K Ramlal Jain, the proprietor of Kawarlal & Co is also operating Nutranol Ingredients through Sundeep Lalwani who is his relative.
Kawarlal &Co had produced documents to show that they had rented out their licensed premises to Nutranol Ingredients which is illegal under the Drugs and Cosmetics Act. Searches were also made at the office premises of Kawarlal &Co and Nutranol Ingredients on April 22-23, 2019.
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