The Committee on Subordinate Legislation, which scrutinises and reports the Indian Parliament about the execution of regulations, rules, sub-rules and by-laws passed by the legislative, has lambasted the Union Ministry of Health and Family Welfare for its vagueness in framing of rules and delay in issuing final notification on such amendments.

The response from the committee is based on the vagueness in specifications of an amendment rule - the Drugs and Cosmetics (First Amendment) Rules, 2008, adding Rule 157 A in the Drugs and Cosmetics Rules, 1945, regarding maintaining of records of raw material used by Ayurveda, Siddha and Unani drug manufacturers in the prescribed performa given in Schedule TA in the Drugs & Cosmetics Rules.

The Committee, in a sitting in mid March, 2010, noted that rule 157 A lacked clarity as to whether each manufacturing unit of Ayurveda or Siddha or Unani drugs is required to keep record of raw materials used by each licensed unit which are manufacturing Ayurveda or Siddha or Unani drugs.

The notification, issued by the Department of Ayush, under the aegis of central ministry of health, specifies that “Each licensed manufacturing unit of Ayurveda or Siddha or Unani drugs shall keep a record of raw material used by each licensed manufacturing unit of Ayurveda or Siddha or Unani Drugs
the case may be in the proforma given in the Schedule TA in respect of all raw material utilized by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in the preceding financial year.”

The words ‘each licensed manufacturing unit’ gives an impression that the manufacturing unit was required to keep a record of raw material used by each licensed unit which are manufacturing Ayurveda or Siddha or Unani drugs, though, it appeared that the intention of the amendment was to maintain a record of raw material used by that particular manufacturing unit only, during the preceding year.

On receiving the note from the committee, the ministry, through an office memorandum in July 2009, has agreed to amend the rule as “Each manufacturing unit of Ayurveda, Siddha, Unani drugs shall keep a record of raw material used by it, as the case may be, in the proforma given in Schedule TA”. Though appreciating the effort to rework the rule, the committee warned the ministry that the ministry should be well aware that the lack of clarity in rules vitiates the purpose of delegated legislation and harms the interest of the general public at large.

“The Committee recommend that the Ministry of Health and Family Welfare should bring about the related amendments as soon as possible. The Ministry should be cautious while bringing out amendments and framing of rules under delegated legislation and make efforts to avoid ambiguity,” said the recommendation of the 15 member committee headed by member of parliament, P Karunakaran. The committee recommended that the ministry should bring about the related amendments as soon as possible.

Adding to the reprimands on ambiguity in wording the rules, the committee has also come down heavily on the ministry for its delay in publishing the final notification, again on the same amendment rule.

The committee seriously noted that “the Ministry of Health and Family Welfare had published the Drugs and Cosmetics (First Amendment) Rules, 2008 in final form after a delay of more than one year in utter disregard to the oft-repeated recommendation of the Committees that the rules, in final form, should be published within six months when large number of objections and suggestions are received on the draft rules and within three months when no objection/suggestion is received on the same.”

The Drug and Cosmetics (First Amendment) Rules, 2008 (GSR 512-E of 2008) were published only in July 2008, while its draft was published in the Gazette of India on October, 2006 (GSR 651-E) inviting objections and suggestions from persons likely to be affected and a period of forty-five days were given for the same.

“The Committee observe that Ministry could have easily adhered to the time limit recommended by the Committee for final notification of the abovesaid Rules had they streamlined their functioning and made serious efforts in this direction,” states the committee recommendation.