The Ministry of Health and Family Welfare vide its notification dated 26th February 2019 has introduced the draft amendment rules to amend the Drugs and Cosmetics Rules 1945 inviting suggestions/comments from the public. The changes proposed are summarised below.
An additional condition has been imposed on certain applicants who wish to obtain licences under the Drugs and Cosmetics Rules, 1945. The applicants shall be required to furnish an undertaking stating that no similar brand names or trade names exist in the market which will lead to any deception or cause confusion in the market. This condition has to be satisfied by the applicants for obtaining the following licences:
- a loan licence[i] or renewal of a loan licence from the authority in Form 25, or a licence/ renewal of the licence for the manufacture of drugs included in Schedule X in Form 25-F.
- a licence for repacking of drugs, the drugs other than those specified in Schedule C and C(1), or renewal of the licence in Form 25-B.
- a loan licence for the manufacture of drugs for sale or for distribution of drugs other than the drugs specified in Schedule C, C(1), and X in Form 25A.
- a licence (in Form 28, 28-B or 28-D) to manufacture (or renewal thereof) for drugs specified in Schedules C and C(1), [excluding those specified in Part XB and Schedule X].
- a loan licence/ renewal licence (in Form 28A or 28DA) to manufacture for sale or for distribution drugs specified in Schedule C and C1 excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs.
- Explanation to Section 69 (A) (1) of the Drugs and Cosmetics Act, 1940- loan licence means a licence which the Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25.
- Draft Rules – http://egazette.nic.in/WriteReadData/2019/198746.pdf
The Ministry of Information and Broadcasting (“Ministry”) vide a public notice has invited comments from the public regarding the proposed Cinematograph Act (Amendment) Bill.
The Ministry proposes stringent penalties for recording, attempting to record or abetting the recording or transmission of a film or part thereof by introducing a new sub-section, that is, sub-section (4) of section 7 in the Act which currently reads as follows:
“Notwithstanding any law for the time being in force including any provision of the Copyright Act, 1957, any person who, during the exhibition of an audiovisual work, cinematographic in an exhibition facility used to exhibit cinematograph films or audiovisual recordings and without the written authorization of the copyright owner, uses any audiovisual recording device to knowingly make or transmit or attempt to make or transmit or abet the making or transmission of a copy or visual recording or sound recording embodying a cinematograph film or audiovisual recording or any part thereof or a copy of sound recording accompanying such cinematograph film or audiovisual recording or any part thereof during subsistence of copyright in such cinematograph film or sound recording, shall be punishable with imprisonment not exceeding three years and shall also be liable to fine not exceeding Rs.10 Lakhs, or to a term of imprisonment for a term not exceeding three years or both.”
The proposed provision uses non-obstante language to over-ride any existing law including the Copyright Act, 1957. This seems unjustified as the objective of the Cinematograph Act is to regulate the certification of cinematograph films for exhibition and that of the Copyright Act is to protect copyright. Hence the piracy issue should have been dealt with by amending the Copyright Act instead of the Cinematograph Act.
Further the proposed provision prescribes a stringent penalty of imprisonment for up to three years with the possibility of an additional fine.
- Public notice seeking comments on the draft amendment to the Cinematograph Act-
- Cinematograph Act, 1952.