The union health ministry is planning to amend the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 with penalty provisions of conviction for a minimum of three years for repeated offenders. The objective is to replace the four-decade old obsolete and weak rules restricting unethical and objectionable advertisements of drugs and cosmetics published in the media.

Besides, the government is planning to constitute a Drugs and Magic Remedies (Objectionable Advertisements) Board, to advice the Central and State Governments on technical matters arising out of the administration of the Act and to carry out any functions defined in detail under the Act.

Pharmabiz learnt that the joint secretary of the Ministry of Health and Family Welfare has sought opinion and comments from few industry leaders and experts a few days ago on the proposed draft amendment bill of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

The proposed amendment, under Section 3, will ban advertisement in relation to any drug, which is to be used for the 'diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition', which may be specified in the rules made under the Act. (The existing act prohibits the advertisement of drugs required for only 51 specified diseases or disorders). In an important initiative to severally punish the culprits, Section 7 of the proposed draft amendment bill seeks to impose a minimum conviction even in the case of first offence, and in the case of subsequent offences, the minimum imprisonment prescribed is three years.

The salient features of the draft include changing the definition of 'drug' in Section 2 (b) to be amended to include the words 'disorder or condition', aimed to include any medical condition. Further, definition of the word 'treatment' has been changed in Clause 2 (f) to mean and include treatment for any 'disease', disorder or condition' and includes any claims made to treat any disease, disorder or condition in human beings or animals.

The proposed Drugs and Magic Remedies (Objectionable Advertisements) Board (DMR-OA Board), to be constituted under Section 6(A), will consist of one member nominated from Pharmaceutical industry, one person amongst the manufacturers of drugs of Ayurveda, Siddha and Unani System of Medicine and one person from the practitioners of Indian System of Medicine. However, the draft has not elaborated the functions and powers of the board, it is learnt.

Further, the draft bill has mentioned that the rules shall be made only after consultation with the Drug Technical Advisory Board (DTAB). Further, it is discretionary on the part of the Government to consult the Ayurveda, Siddha, Unani DTAB (ASUDTAB), instead of the present option to consult any person having special knowledge or practical experience in respect of ISM drugs.