Last Updated on April 12, 2021 by The Health Master
These include Section 1(3), Section 2, Section 3(c) and Section 3(h).
In its communication to the Union government, the Federation has highlighted the unnecessary sections of the drug regulations and cited that these are seen to be non-implementable.
These include Section 1(3) Proviso with reference to Jammu and Kashmir as the rule is redundant after enactment of J&K Reorganization Act, 2019.
In Section 2 words Dangerous Drugs Act 1930 has been repealed and therefore needs to be omitted.
Section 3(aaa) in definition of cosmetic word or animal needs to be added after human as now many pet products such as pet shampoo, pet deodorant, etc. are manufactured and available in the market, said BR Sikri, chairman, FOPE.
Latest Notifications: D&C Rules 1945
Under Section 3(h) the word patent has no relevance and should be omitted because it is regulated in another independent Act, he pointed out.
“Though, the intention of such guidelines was to provide relief to the law-abiding manufacturers against prosecution even for unintentional mistakes, many aspects are not relevant to the current context,” Sikri told.
However, because of the DCC Guidelines approved in 1993, the regulatory officers are resorting to prosecution strictly based on mathematical consideration.
It is necessary to provide certain statutory support to reflect the principles laid down in the directions issued under Section 33(p).
In view of these, the existing Section 32(B) should be substituted with new section providing for compounding of all offences except offences related to adulterated and spurious drugs.
This will reduce the burden of regulators also, he said.
Further, there is a need to distinguish between formulations, active pharmaceutical ingredients (APIs) and non active ingredients (excipients).
Existing definition of Drugs includes bulk drugs and components of drugs like non achieved ingredients or excipients.
As a result wherever the term drug appears in the Act, it is construed to include bulk drug as well as excipients and all provisions applicable to formulations also apply to bulk drug.
Therefore, there should be separate definition of formulations, active substances and non-active substances.
In addition, there should also be independent provisions specially for labelling and manufacturing of formulations, bulk drugs and excipients, said the FOPE chairman.
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