It was stated that the exercise to amend the rules is invalid, and proper procedure is not being followed since the Drugs Technical Advisory Board has to be consulted before the Draft Rules are prepared and published for inviting comments. The notification dated 28.08.2018 also states that after consultation with the Board, the Draft Rules are being published, whereas the RTI reply reveals that no such consultation was held before framing Draft Rules.
It was also submitted that the matter was put up before the Board in November 2018, and that too without placing all relevant information. The DTAB in the year 2015 has stated that online sales in contravention of rules should not be permitted. Further, a Sub – Committee of the Drug Consultative Committee in the year 2016 had made extensive suggestions for e-pharmacies to be permitted. However, the same have been ignored by the Central Government while framing the current Draft Rules.
It was submitted that the Draft Rules have serious shortcomings on sale of drugs as well verification of prescriptions. These issues were elaborately dealt with in the report of the Sub – Committee of the Drug Consultative Committee in the year 2016.
After extensive hearing, the Central Government agreed to consider fresh representations, to be filed by the two associations, against the draft rules proposing to amend the Drugs & Cosmetics Rules. The Associations have been directed to submit the representations within 3 days.
The AIOCD was represented by Mr. Jayant Bhushan, Senior Advocate and Mr. Nakul Mohta. On behalf of the SCDA, Mr. Amit Gupta, Advocate appeared.