The State Drug Regulator of Kerala, M P George, has submitted a set of comprehensive suggestions to the Drug Controller General of India (DCGI) in the context of ongoing process of amendment to the Drugs and Cosmetics Act 1940. He made the proposal in the wake of a decision made at the 39th Drugs Consultative Committee (DCC) held on December 10 last year.
The DCC was held prior to the Union health ministry's decision to entrust the supreme control of drugs with the national drug regulatory agency and to enforce the uniform drug standards in the country. Besides, the health ministry is pursuing the amendment of the D&C Act to bring into effect more stringent penalties for those involved in counterfeit drugs.
The regulators' committee had constituted four sub committees to suggest views for the process of amendment of the Act. As per the decision, the sub committees were given the tasks of analyzing various issues related to spurious drugs, medical devices, drug testing norms and e-governance, and advised to submit their reports with in two months.
George, belonging to three sub committees, has called for a thorough overhaul of Drugs & Cosmetics Act to make a transparent and uniform drug regulatory system in the country.
"Hitherto the amendments have been made in piecemeal which have caused innumerable repetitions and illustrations of each rule are covered in so many pages that make the text too big to be handled. So many omissions are required in several pages, and the rules to be observed are scattered in various sections in different part of the book. Therefore, as a prime focus, the size of the text has to be reduced by bringing all common provisions like conditions of license printed in the Forms, definitions, etc into one general part. The fee structure for fresh registration, renewal, fine, duplicate, etc can be included in another one rule. All labelling provisions could also be brought in one rule," he felt.
He suggested that there should be specific sections for modern drugs, Homoeopathic, Ayurveda, blood bank, medical devices, sera & vaccines, clinical trials, import and export and registration. "Once we do a thorough study of the Act, it can be easily found that the number of Forms for licenses have to be reduced," George said.
He said there are so many rules for keeping medicines and maintaining a pharmacy by a chemist under the provisions of D&C Act. Even for regulation also, a number of rules are there in the Act. Some of them are to be scrapped and some of them may be transferred to another section. For instance, Schedule F1, 2, 3 of the Act can be transferred to Schedule I P for convenient reference. Form 17A is not necessary, instead, refusal can be recorded in Form 15, into which address of the inspector can be added.
The drugs controller has suggested that the Act requires a common model, as there are errors in many Forms. He said there is no specification about whether the party should be given the original copy or copy of Forms of an action taken by a regulator. Likewise the conditions of license under Rule 65 have to be modified completely.
Currently no rule in the Act proposes for computer bills, it has to be there. In Schedule M, it has to be differentiated between registers and records.
There should be provision for testing any drug or cosmetic in the laboratory rather than separate approval for ayurvedic drugs. In one approval, one should be able to specify what things could be tested.