The Maharashtra State Chemists & Druggists Association may soon approach the state Food and Drug Administration (FDA) for an extension of the deadline of December 31, 2004, set for changeover to air conditioning the facilities of the existing retail chemists. The association feels that the deadline set is too short for the medical shops in the state to comply with. Moreover highly placed officials of All India Organisation of Chemists and Druggists told that the chemists were confused about the unclear, confusing and incomplete guidelines for AC compliance issued by the state FDA.
"The FDA did not issue a clear guideline explaining AC compliance and related requirements. Only a circular was issued informing about the deadline for compliance. Circular is not clear about specifications like the minimum area needed for a single AC installation, number of ACs for a bigger area, whether the shop has to be partly or fully air-conditioned, etc. What would the FDA do if the area of the shop is twice or thrice the minimum area, but the shopkeeper has installed only a single AC in his shop? All these factors have to be specifically mentioned," said the MSCDA official.
"Very soon, we would be holding meeting with the commissioner of Maharashtra FDA to discuss these issues," said a highly placed official in MSCDA. When contacted by Pharmabiz.com FDA officials refuted the claims made by MSCDA about incomplete circular.
Uttam Khobragade, commissioner, Maharashtra FDA, said, "I think a changeover time of 18 months is more than enough for the pharmacies. FDA will take strict actions against those retailers who are not AC compliant after December 2004."
MSCDA officials however maintain that without proper guidelines it is confusing for the chemist to install AC. "Besides what about the chemists who cannot afford it. It does not look practical at all," he said. "What we want is the deadline to be extended by 2 to3 years with specifications. This would also give adequate time for the smaller medical shops to become AC compliant," he added.
Maharashtra, which introduced the rule for new medical shops from January 1, 2003, has issued about 300 fresh trade licenses with this condition. The FDA, Maharashtra has made air conditioning of the premises of all the wholesale and retail drug outlets mandatory in Mumbai and grade A and B municipal areas. About 10,000 medical shops fall under this area limit in the state. The FDA move in this direction is in the wake of an investigation report, which has revealed that the potency of many life saving drugs get reduced by up to 50 per cent if they are not stored below 25 degree centigrade.
Meanwhile, FDA has ensured that new medical shops opened in the state after January 2003 is AC compliant. In Mumbai alone there has been an addition of 70 to 75 new medical shops this year. The FDA officials maintain that all of them are AC compliant. However, MSCDA officials said that without proper guidelines, the new medical shops could always find a route to circumvent the rule.