Dr. G. N. Singh,
Drugs Controller General of India (DCGI)
Secretary-cum-Scientific Director, IPC
Chairman – Drugs Consultative Committee (DCC), Ministry of Health and Family Welfare, Government of India
Talking forward the vision of patient safety and public health, Dr. G. N. Singh, Drugs Controller General (India) (DCGI) and Chairman, Drugs Consultative Committee (DCC) suggested that state drug controllers have to take forward the agenda enumerated below for public health and patient safety.
DCGI requested all State Drugs Controllers to appraise about the implementation of earlier decisions deliberated in the 51st DCC regarding the signing of MOU with Central Government implementation of regulations for ease of doing business, sharing of online information regarding manufacturing, sales and product licences for uploading on CDSCO website, harmonization of drug regulatory system having uniform pay scales and infrastructure etc.
Members suggested to develop a common software database for issuance of licences comprising list of approved, unapproved and banned drugs. The software should have the capability of detecting the applications containing unapproved or banned drugs in full or part.
The Director General, Drugs Control Administration, Andhra Pradesh, explained about the challenges he is facing for implementation of D& C Rules as the State Government is not having any permanent office. He also requested to have a dedicated office of CDSCO at Vishakhapatnam (Vizag), as most of the imports and exports are now being carried out from Vizag Sea and airports. He also mentionedabout the issue of antibiotic resistance due to the usage of feed supplements in most of the coastal districts of Andhra Pradesh, where there is no regulation for misuse of antibiotics in the feed supplements and other non-medicinal items used in pisiculture.
The Drugs Controllers, Odisha, Goa, Gujarat, Maharashtra, Nagaland and other states expressed their concerns regarding non-release of the allotted funds assured in the earlier meetings to strengthen their regulatory system within their targeted timeframe.
DCG (I) also suggested a policy for inclusion of these issues in the draft NPP, 2017 like public confidence on quality of drugs, autonomy for Drug Regulators, creation of Indian Pharmaceutical Services, High powered Advisory Body, policy on Fixed Dose Combinations (FDC) / Clinical Trials / Medical Devices, approach towards International Cooperation, role of regulators in promotion of innovation, maintenance of regulatory data, strengthening the Pharmacy practice, strengthening of drugs regulatory system, strengthening of regulations, policy on online pharmacy, promotion of generics and policy for prohibition of drugs due to lack of rationality, lack of efficacy etc.
Drug Technical Advisory Board (DTAB) Agenda –
Measures for uniform implementation of provisions of drugs & Cosmetics act and rules throughout the country
The DTAB agreed following recommendation of the DDC for strengthening Drug Regulatory System in the Country to ensure effective and uniform implementation of the provision of act and rules, 1945.
1) Cadre restricting in state drugs controls for uniform implantation of provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945
- The post of Drugs inspector should be re-designated as Drugs control officers.
- The grade pay of drugs inspector should be raised to Rs. 5400 in pay band-2.
- The grade pay of Assistant Drugs Inspector should be raised to Rs. 4800 in pay band-2.
- All the other higher posts should accordingly be re-organized.
2) The central Govt. should issue direction to the state government to ensure adequate regulatory officials which will be commensurate with the number of sale outlets and manufacturing units located in the respective sates considering that there should be one officials for every 200 sale outlets and one official for every 50 manufacturing units.
3) There should be provisions for deputation of State Regulatory officials to the Central regulatory system and vice versa.
4) The minimum experience for Licensing for Licensing Authorities (LA) relating to manufacturing and sale of drugs should be raised adequately.
5) The practice of having multiple LA in a state for regulation of manufacture of drugs may be replaced by a single LA with provision for delegation of powers to other regulatory officials.
6) Guidelines, direction as and when issued, should be communicated to the state government and not to the state drugs controllers for ensuring effective uniform implementations of such guidelines directions.
7) It was suggested that drugs control authority of each state should create an intelligence cell with a nodal officer for market surveillance and conducting investigation in respect of spurious, adulterated drugs in co-ordination with CDSCO.
8) Drugs samples from supply chain of procurement agencies needs focused monitoring for ensuring equality of the drug.
9) The procurement agencies get their sample tested at approved private drug testing laboratories and obtain test reports in form 39, which is supposed to be issued by such laboratories only to drug manufacture who do not have testing facilities. The drug and cosmetic rules, 1945 should be amended to prescribe a separate form for issuing test reports by such laboratories for procurement agencies.
10) The committee while appreciating the recently conducted national drugs survey, mentioned that a system should be put in place to address issue, if any relating to the survey, when brought to the notice of the authority.
11) Guidelines should be prepared for disposal of expired drugs – a committee comprising drugs controllers of Telangana, MP and DDC (I), Hyderabad zone should be constituted in this regard.
12) Weak areas of market identified on the basis of risk analysis and intelligence information shall be kept under active quality surveillance of GAP by conducting special operations.
13) Regulatory officials should not participate in the procurement activities as there may be conflict of interest.
14) Minutes of al DCC and DTAB meeting held so far should be compiled and uploaded in CDSCO website.
15) The medical device officers to be appointed under the rules should have B. Pharm / M. Pharm. Such officer should undergo training in medical device regulation under a training module being developed under joint collaboration between Delhi pharmaceutical science and research university and IPC, Ghaziabad or nay other institutions which deems fit for such activity.
16) Uniform nomenclature on the pattern of earlier proposal of naming CDCSO as Indian drug Administration. Likewise, in the states whether they may be named as IDA (Name of the State/FDA/name of the institution).
