Microorganisms found in Dabur India, Shree Baidhyanath drugs
KATHMANDU, Sept 25: The government has suspended the import of medicinal powers produced by two Indian companies, Dabur India Ltd. and Shree Baidhyanath Ayurved Bhaban, for an indefinite period.
The move comes after the presence of microorganisms was detected in the two companies´ products of several batches.
The Department of Drug Administration (DDA) under the Ministry of Health and Population (MoHP) said that such problems had been encountered last year also in those companies´ products.
DDA, a national regulatory body that ensures quality drugs for the general public by controlling production, distribution, sale, export and import, said that it has issued directions to recall all the medicines in the tainted batches exported to the Nepalese drugs market. However, DDA inspectors are unaware whether the contaminated medicines were actually recalled from or not.
“We have sought clarifications from the companies and halted imports for an indefinite period, DDA Director General Radha Raman Prasad said.
DDA had recalled contaminated products of the two companies last year also. The office had sent letters three months ago demanding all records of the drugs production but the companies have not yet sent any representatives to furnish clarifications.
DDA said that the presence of microorganisms was found in seven products: Trifala Churna of AL092 batch, Lavanbhaskar Churna AL0733, Avipattikar Churna AL0004, Shatawaryadi Churna AL0027, Ashwagandha Churna AL 004, Panchasakar Churna AL0066 and Tallisadi Churna AL0031 of Dabur India Ltd.
Likewise, three products of Shree Baidhyanath Ayurved Bhawan -- Pushyanug Churna 4, Mahasudharshan Churna 3 and Chopchinyadi Churna 6 -- were also found problematic.
DDA said the microorganisms were also found in these products. Doctors say that several health complications occur if patients use drugs in which the microorganisms are present.
23 drugs recalled, 18 of Indian firms
Out of 98 medicines analyzed in the laboratory, 23 were found problematic, DDA said.
Among these, 18 were from Indian companies.
The office said that the medicines were recalled from the market last fiscal year.
DDA also said problems were found in government-supplied medicines. The office said that government-supplied iron supplement (Stalferic Tab) produced by Stallion Laboratories Pvt. Ltd. had packaging defects and it had ordered its recall.
Similarly, black particles were seen in Mannitol Injection 100 ml of batch TBIOD2, which is produced by Tablet India, and in Metronidazole injection batch 1101P033 produced by Parental Drugs, India.
The color had changed in Dobufast injection of 89128 batch produced by Indian company Neon Laboratories and DDA had asked for its recall from the market.
The office also asked to recall six products of five Nepalese companies.