Union Health Ministry is planning to make amendment to the Drugs and Cosmetics (D&C) Rules to increase the period of retention of documents from the manufacturers and also the control of samples for a greater time as part of tightening the monitoring quality of drugs.
The proposal, which is now under the consideration of an expert panel, is to amend the rule 65 (7) of the D&C Rules to increase the period of retention of documents, registers etc., for a period from two years to five years in line with the provision for maintaining manufacturing records.
Another proposal, being seriously considered is to amend Rules 74 and 78 with regard to retaining control on samples. As per the suggestion, the duration will be increased to five years from the date of manufacturing or three months from the date of expiry, whichever is later, sources said.Since the manufacturing records are required to be maintained for a period of five years from the date of manufacturing, it is appropriate to make it mandatory that the corresponding control on samples are also retained for the said duration, according to the recommendation.Both the proposals came up for discussion also at the Drugs Consultative Committee sometime back and the DCC referred them for further consideration by a sub-committee, sources said.
The Government is also planning a couple of other amendments to make the rules updated and in tune with the changed circumstances.
One another proposal is to amend Rule 143 of the Act. As per Rule 85 of D&C Rules, 1945 licensing Authority is having powers to issue Stop Production Order in respect of manufacture of drugs. However such type of provision is not included under Rule 143(Licensing Authority is having powers to suspend/cancel the cosmetics license only). Hence necessary amendment may be made under Rule 143 for issue of Stop Production Order
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