Last Updated on February 4, 2021 by The Health Master
The Federation of Pharmaceutical Entrepreneurs (FOPE) is of the view that there is a need for a contemporary identity for the existing Drugs and Cosmetics Act, 1945 and it has proposed for a name change to Medicines, Medical Devices and Cosmetics (MMDC) Act, 2021.
The Federation also noted that certain provisions are redundant in the D&C Act and presses for its revision. These include replacing the word ‘drug’ with medicine.
The intend, according to FOPE, comes in when the Indian pharma industry is zipping through the fast lane proving itself to be indispensable in drug supplies for the global market, particularly during this C-19 pandemic.
Here the Federation views that in an age where drug abuse is rampant, the country’s regulatory framework credentials need to be revised to be far more relevant in the current advanced ecosystem.
There is an urgent need to revisit the entire Act and Rules especially in view of notifications of Medical Device Rules 2017, New Drugs and Clinical Trials Rules, Cosmetic Rules 2020 which have made many contradictory provisions in Rules having no applicability to the Drugs Act.
Therefore D&C Act and Rules and other Medical Device Rules, Clinical Trials Rules and Cosmetic Rules 2020 needs to be revisited.
It is recommended a committee of all stakeholders including the CDSCO, state regulators and industry may be constituted and directed to submit report in a stipulated timeframe, said BR Sikri, chairman, FOPE.
“It is here we strongly recommend that the existing drug Act to be MMDC, 2021. This is contemporary, relevant and an effort to replace the seven decade-old title when both the Indian pharma industry and the new rules for manufacture of novel formulations and medical devices come in,” Sikri told Pharmabiz.
It is not just the title of the regulation but existing designations like ‘Inspector’ needs to be changed to Medicines Regulating Officer (MRO) or Medicines, Medical Devices and Cosmetic Regulatory Officer (MMDCRO).
In this in tune with the Prime Minister Narendra Modi mentioning that erstwhile ‘Inspector Raj’ needs to be exited, he added.
Besides this there is a need for suitable provision to enable DCGI to issue guidelines to state drugs controllers for effective and uniform implementation of the Act and Rules, said Sikri.
At present for any violation of conditions of manufacturing and selling license there is a provision of suspension or cancellation.
But FOPE feels an opportunity needs to be given to the licensee for improvement in compliance. Penal action may be taken only if licensee fails to improve compliance.
Moreover, in the cases of prosecution in the court, the issue is dragged for 10 to 15 years causing a big burden on the regulatory department because of inadequate manpower.
Therefore, the provisions for compounding and for adjudication for all offences except those related to spurious and adulterated drug, should be made compoundable. There should also be a concept of ‘self audit or 3rd party audit to be included in the Act.
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