The Bombay High Court of Goa has directed the Union of India and the Ministry of Consumer Affairs, Food and Public Distribution to decide the representation seeking direction to frame and adopt the Standard Method for design and layout for package insert.

The Division Bench of Justice M.S. Sonak and Justice Bharat P. Deshpande disposed of a Public Interest Litigation (PIL) filed by one Manoj Solanki seeking the following reliefs:-

“a. This Hon’ble Court be pleased to direct the Respondents to frame and adopt the Standard Method for design and layout for package insert. The font size of the information printed on the package inserts should be easily readable and patient friendly specifying a minimum standard font size. 
b. This Hon’ble Court be pleased to direct the Respondents that besides English language, package inserts should be in Hindi language as also in vernacular languages.

c. This Hon’ble Court be pleased to direct the respondents to revise Drugs and Cosmetics Rules 1945 Rules to better suit the needs of patients with respect to package inserts. 

d. This Hon’ble Court be pleased to pass such other orders as may be deemed necessary in the interest of justice.” 

Considering the nature of reliefs applied for by the Petitioner, the Bench observed that the petition would be considered as a representation by the petitioner addressed to Respondent No 1 (Union of India) and 2 (Ministry of Consumer Affairs, Food and Public Distribution).

Moreover, the petitioner has placed on record representations seeking similar reliefs addressed by the Indian Medical Association (Goa Branch) to the Respondents.  

Accordingly, the Court directed Respondent No 1 and 2 to treat this petition as a representation and dispose of the same as expeditiously as possible. 

“The concerned officials of Respondent Nos 1 and 2 are to communicate their decision to the petitioner within a reasonable time. If the petitioner wishes to place before the authorities any further material in support of his representation, the petitioner should do so within a month from today. Such additional material should also be considered by the concerned authorities,” the Court further directed.