Health Ministry Releases Draft DMR Amendment Bill, 2020

Mumbai, 5 Feb 2020:

The Union health ministry has released the draft Drugs and Magic Remedies (Objectionable Advertisements) (DMR) (Amendment) Bill, 2020 for effective compliance.

The ministry’s initiative in this regard comes close on the heels of concerns raised at several quarters on implementation and effectiveness of the DMR Act, 1954.

The proposed draft bill clearly defines Advertisement, Penalty and the disorders covered under the ambit of the Act which shall be called the Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Act, 2020.

As per a notice, “Ministry of health and family welfare, Government of India proposes to amend the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 in order to keep pace with changing time and technology. In this regard, a draft bill has been prepared and released to solicit suggestions, comments, objections from the public or stakeholders with regard to the said draft Bill.”

“The suggestions, comments or objections may be forwarded within 45 days from the date of issue of this notice by email at drugsdiv-mohfw@gov.in or by post to Under Secretary (drugs Regulation), Ministry of health and family welfare, Room No. 414 A, D Wing, Nirman Bhawan, New Delhi - 110011,” the notice stated.

In the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (hereinafter referred to as the principal Act), in section 2, for clause (a), the following clause shall be substituted, namely (a) "advertisement" means any audio or visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website and includes any notice, circular, label, wrapper, invoice, banner, poster or such other documents provided that label or wrapper is an advertisement only if it contains any information or claim other than provided in the rules."

In the principal Act, in section 3, in the clause (d), (a) in sub-clause (ii) at the end, the word "or" shall be inserted; (b) after sub-clause (ii) so amended the following sub-clause shall be inserted namely (iii) after consultation with Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (DTAB) constituted under section 33C of the Drugs and Cosmetics (D&C) Act, 1940 in respect of Ayurvedic, Siddha and Unani system of medicines."

In the principal Act, for section 7, the following section shall be substituted, namely "Penalty.— Whoever contravenes any of the provisions of this Act [or the rules made thereunder] shall, on conviction, be punishable— a) in the case of first conviction, with imprisonment which may extend to two years and fine upto ten lakh rupees, in the case of a subsequent conviction, with imprisonment which may extend to five years and fine upto fifty lakh rupees."

In the principal Act, in the section 8 (2), for the words and figures "the Code of Criminal Procedure, 1898 (5 of 1898)", the following shall be substituted, namely "the Code of Criminal Procedure, 1973 (2 of 1974)".

In the principal Act, in the section 9A, for the words and figures "the Code of Criminal Procedure, 1898 (5 of 1898)", the following shall be substituted, namely “the Code of Criminal Procedure, 1973 (2 of 1974)".

In the principal Act, for the schedule, the following schedule shall be substituted, namely “The Schedule [See section 3(d) and 14]”.

Name of the disease, disorder or condition covered under the draft bill are AIDS, angina pectoris, appendicitis, arteriosclerosis,  blindness, blood poisoning, bronchial asthma, cancer benign tumor, cataract, change in colour of hair and growth of new hair, change of foetal sex by drugs, congenital malformations, deafness, diabetes, diseases and disorders of the uterus, epileptic fits and psychiatric disorders, encephalitis, fairness of the skin, form and structure of the breast, gangrene, genetic disorders, glaucoma, goitre, hernia, high or low blood pressure, hydrocele, insanity, increase in brain capacity and improvement of memory, improvement in height of children or adults, improvement in size and shape of the sexual organ and in duration of sexual performance, improvement in the strength of the natural teeth, improvement in vision, jaundice or hepatitis or liver disorders, leukaemia, leucoderma, maintenance or improvement of the capacity of the human being for sexual pleasure, mental retardation, sub normalities and growth.

It also includes ailments like myocardial infarction, obesity, paralysis, parkinsonism, piles and fistulae, power to rejuvenate, premature ageing, premature greying of hair, rheumatic heart diseases, heart disease, sexual impotence, premature ejaculation and spermatorrhoea, spondylitis, stammering, stones in gall-bladder, kidney, bladder, varicose vein, bright's disease, diseases and disorders of brain, disorders of menstrual flow, disorders of the prostatic gland, dropsy, female diseases (in general), hysteria, infantile paralysis, leprosy, lockjaw, locomotor ataxia, lupus, plague, pleurisy, pneumonia, rheumatism, ruptures, smallpox, sterility in women, trachoma, tuberculosis, typhoid fever, ulcers of the gastro-intestinal tract, venereal diseases, including syphilis, gonorrhoea, soft chancre, venereal granuloma and lympho granuloma, pyorrhea and sensitive teeth. Pharmabiz