In what can turn out to be a Pandora's Box of illegal trade of importing of bulk drugs from China, a Ludhiana-based pharma trader has imported huge quantities of theophylline from an unregistered source in China. Theophylline is used for making anti-asthma drugs.
According to sources, the Ludhiana-based importer has imported more than 500 tons of bulk drugs of theophylline in April this year alone from an unregistered source in China, which the experts say is enough to cover the entire countries demand for more than one year. Theophylline is a price controlled drug, and the NPPA has fixed its price at Rs.512 per kg.
Interestingly, after the huge import of theophylline in April this year from China by this importer, the price of this drug in the local market has crashed by as much as 10 per cent and the price now rules at Rs.450 per kg in the local market. Experts said that the crash of 10 per cent is a big setback to the local manufacturers of theophylline as the profit margin of the drug ranges from 5 to 10 per cent only.
Meanwhile, the modus operandi of the importer is that the description for each 25,000 kg import is mentioned as “CRUDE THEOPHYLLINE 80 per cent W/W (WET ) LOSS ON DRYING NLT 15 per cent (20365 KGS ON DRY BASIS)”, which the experts in the trade say is mischievous.
Experts contend that the obvious purpose of such a long description appears to somehow show that the item imported cannot be covered under the definition of a bulk drug in the stricter sense as the content is less than 85 per cent. But rest is only water. No bulk drug can be imported into the country without it conforming to a pharmacopoeia which is applicable even if the import is under advanced license or by an
EOU.
Meanwhile, the Indian Drug Manufacturers’ Association (IDMA) has submitted a memorandum to the Drugs Controller General of India (DCGI), Dr Surinder Singh, asking him to investigate the matter and put an immediate stop to such unhealthy practices, which will have a negative impact on Indian bulk drug industry. “If such imports are permitted unrestricted in the country, then it will give a backdoor entry to all Chinese drugs from unregistered sources,” IDMA in its memorandum to the DCGI said.
Source : pharmabiz.com