No opinion’ from drug lab stumps FDA

  • News
  • April 15, 2016

Nashik

The Nashik Food and Drug Administration (FDA) is in a fix as the drug control laboratory has expressed “no opinion” on the oxygen sample it had sent a couple of months ago to check if it was fit for medical use.In February, the FDA had raided an oxygen plant in Sinner and seized oxygen cylinders worth Rs 1.55 lakh. The oxygen manufactured in the plant was meant for industrial use, but the management was allegedly supplying it to a hospital, which is illegal according to the Food and Drug Administration Act. Taken aback by the lab’s reply, the FDA has asked it to be more specific. The officials said they are not in a position to interpret the report for further course of action against the establishment concerned from where the gas was seized. The management of the plant was found supplying oxygen cylinders to a multi-specialty Hospital in Sinner. As many as four cylinders were also been seized from the hospital so that the oxygen for industrial purpose was not administered to the patients, which could prove hazardous owing to ambiguity over its purity. FDA officials said the oxygen plant had acquired license from the Controller of Explosives of the government of India. However,

the industrial unit did not have the FDA’s license and hence, it was not authorised to supply oxygen to hospitals. “According to the Indian Pharmacopeia standards, oxygen used for medical purpose comes under the category of drugs and has its own norms of purity and other specifications. The company concerned should have acquired the FDA’s licence for supplying it to hospitals. However, the management of the company used a special colour coding by painting a white collar to a cylinder painted in black to supply it to the hospital. This raised suspicion that the oxygen cylinders for industrial purpose were used for medical purpose,” said Bhushan Patil, additional joint commissioner of FDA (Nashik). As part of the investigation, the oxygen sample was sent to the state drug laboratory in Mumbai to check if it was safe for administering it to human beings. Patil said, “We were expecting some specific reports about oxygen sample. However, the lab replied expressing no opinion on whether the sample was of standard quality.” FDA officials said they have written back to the drug control laboratory in this regard. The company concerned should have acquired the FDA’s licence for supplying it to hospitals. However, the management of the company used a special colour coding by painting a white collar to a cylinder painted in black to supply it to the hospital. This raised suspicion that the oxygen cylinders for industrial purpose were used for medical purpose.

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