AIDCOC

Neha Shoree Monga AIDCOC-NIPER Medal

7th IPHEX

IPCA President

Office Bearers 2019-21

2018 Best Drugs Control Officer Award

AIDCOC Support to Kerala

AIDCOC Training 2018

Felicitation

66^th IPC

WORKSHOP

ACTIVITIES

Strengthening in North East Zone

a) The golden jubilee of the Institute of Pharmacy, Jalpaiguri: Golden Pharmacy - 1998 was celebrated during 5th to 7th November 1998. The office bearers of AIDCOC, officers from West Bengal from North East Zone States participated in the function and this opportunity was utilized by organizing a meeting of officers from North East Region. During this meeting, the confederation resolved to file writ petition in the Supreme Court for issuing directions as regards implementation of Rules 49, 49(A), 50 and 50(A) of the Drugs and Cosmetics Rules, 1945.

b) Meeting at Tripura: The meeting of North East States Officers was organized on 9th November 2002 at Tripura after conclusion of a workshop on "Prevention of non medical use of drugs" by the Tripura Drugs Control Officers Association. The decision was taken to pursue the earlier decision to form a forum of north East State under AIDCOC. It was also decided that Shri. R.E Lotha, Additional Drugs Controller, Nagaland will act as a convener and will take necessary steps to form the forum in consultation with the President and Secretary General of AIDCOC.

c) Meeting at Shilong: The President, AIDCOC convened the meeting of Meghalaya Drugs Control Officers at Shilong after the inaugural function of National Pharmacy week celebrations and apprised the officers about AIDCOC's various initiatives. Earlier, while speaking as the Guest of Honor, he strongly appealed the Health Minister, Meghalaya to take immediate steps for strengthening of Drugs Control Organization in Meghalaya.

d) Meeting at Aizawal: The conference of north Eastern States Drugs Control Officers was organized by the Mizoram Drugs Control Officers' Association at Aizawal, Mizoram on 25/11/2005. The theme of the conference was "Effective Drugs Control Mechanism - the need of the region" in which Shri. Ravi Uday Bhaskar, Secretary General, AIDCOC, delivered a key note address. During the meeting held after conclusion of the inaugural function, it was decided that the North East State Officers would implement the national project on consumer awareness launched by the AIDCOC. It was also decided that representation should be submitted to the North East State Hill Development Council for strengthening the Drugs Control Organizations and creating independent Drugs Control Administration in each state in the north east region.

Convention	Year	Place
Fourteenth Convention	2010	Shimla
Twelfth Convention	2009	Chennai
Eleventh Convention	2008	Mumbai
Decennial Convention	29th-30th April 2006	Visakhapatnam
Eighth Convention	10th October 2004	New Delhi
Sixth Convention	17th November 2002	Bangalore
Fifth Convention	1st November 2001	Mumbai
Fourth Convention	2000	Hyderabad
Third Convention	1999	Indore
Second Convention	1998	Mumbai
First Convention	December 1997	Thiruvananthapuram

For more details, visit http://www.aidcoc.in/conventions.html

Awards of Excellence

With a view to recognize excellence in Drugs Control Organizations, the AIDCOC has instituted the Best Drugs Control Officers’ Award from 1998. The Best Drugs Control Officers’ Award has been presented to the following officers during the inaugural function of Indian Pharmaceutical Congress.

From 2001, AIDCOC also instituted the Best Drugs Inspectors’ Award to be presented to one Drugs Inspector from each state and CDSCO. The award is presented every year during the inaugural function of the Annual Convention of AIDCOC. From 2001 to 20010, 43 Drugs Inspectors have been presented with the Best Drugs Inspector’s Award during the inaugural function of AIDCOC – 2001, 2002, 2004, 2006 and 2010.

For more details, visit http://www.aidcoc.in/awards.html

Seminars, Workshops and Training programs

Right from its formation, AIOCOC has placed "Achieving professional excellence through self initiative, “very high on its agenda. As a part of this agenda, AIDCOC organized seminars, workshops and traininq programs on legal, technical and management issues for the benefit of regulatory officers and professionals from different facets of Pharmacy field.

1) Panel Discussion: The panel discussion on “Role of Regulatory Officers in Total Quality Regulatory Officers in Total Quality Management was organized at KMK College of Pharmacy, Mumbai on 03/12/1997. Dr. M. Venkateswarulu and Shri. R.W. Gudal participated in the panel discussion and Shri. v.c. Sane, Retired Commissioner, FDA, Maharashtra chaired the panel discussion.

2) Towards Open Drugs Control Organization: The seminar on "Towards Open Drugs Control Organization" was held at BARC, Mumbai on 26/07/1998. Padmashree Anil Kumar Lakhina made a presentation on "FDA- Maharashtra- Experiment in creating open system through information technology." He appreciated the efforts of AIDCOC and hoped that such initiatives by AIDCOC will enable the Drugs Control Organizations to become proactive and consumer friendly organizations with transparency and scientific attitude.

3) Seminar on Nutraceutical - Emerging trends - Regulatory Scenario: AIDCOC in collaboration with regulatory division of IPA organized one day seminar on Nutraceutical - Emerging trends - Regulatory scenario at Mumbai on 17/03/2001. The experts from pharmaceutical industry, Ayurvedic industry and regulatory agencies made presentations during a seminar which was attended by 200 delegates from Pharmaceutical and Nutraceutical field.

4) Orientation Training Program on Solid Dosage Form: The AIDCOC organized a two days training program on "Good Manufacturing Practices" for the benefit of shop-floor and middle level chemists working in small scale industry. The program was organized at FDA's conference room jointly with the Industrial Pharmacy Division of IPA.

5) "Seminars on Schedule M":
i) AIDCOC organized two days program on "Thrust area and implications of the amended Schedule M" exclusively for the benefit of small scale pharmaceutical industry with active cooperation from the All India Small Drugs Manufacturers Association. The program was organized as a follow up action of the steps initiated by the AIDCOC with a view to improve the level of compliance of the GMP.

ii) AIDCOC supported Nashik Division Drugs Manufacturers' Welfare Association to organize one-day seminar on amended Schedule M at Nashik on 17/08/2002. The objective of the seminar was to sensitize the manufacturers on the amended provision of Schedule M, their obligations under the law and to assist them to evolve the strategy for compliance of Schedule M before the stipulated deadline i.e. 01/01/2004. AIDCOC also supported IPA, Baroda to organize similar seminar.

6) Seminar on New drug development and registration: The seminar on new drug development and registration was organized on 07/01/2001 at Chennai in association with the regulatory affairs division of IPA. Earlier AIDCOC had organized one day seminar on TRIPS and Patent Relevance to Pharmacy Industry jointly with IPA at Hyderabad.

7) Pharmawave -2002: The AIDCOC supported Pharmawave 2002: Two days symposium and workshop organized by the Technical Officers' Association, West Bengal at Kolkata on 9th and 10th March 2002.

8) Workshop's at Tripura: i) Workshop on Spurious Drugs: The Tripura Drugs Control Officers' Association organized workshop on "Spurious Drugs". With support from AIDCOC, the officers from North East region participated in the workshop in large number. The program was well covered by the press and electronic media. ii) Prevention of non-Medical use of drugs: The workshop was organized at Tripura on 09/11/2002 with active support and participation of AIDCOC.

9) Workshop on "Web of Aseptic Processing: Pursuing the agenda of interactivity and coordination, AIDCOC joined hands with Millipore India and organised two days workshop on "Web of Aseptic Processing at Bangalore on 15/11/2002 and 16/11/2002. Another workshop on the same subject was organized jointly with Millipore at Bangalore on 14/02/2005 and 15/02/2005. This workshop was organized as a follow up of first such workshop earlier organized at Bangalore. Both programs were appreciated by the delegates.

10) Workshop on access to medicines: AIDCOC participated in the workshop on access to medicine jointly organised at Kolkatta by FMRI, WHO and other NGOs. The activities and the initiatives taken by the AIDCOC on consumer education were presented during the workshop. The resolution passed at the conclusion of workshop has incorporated AIDCOC's viewpoints, especially, on need to strengthen Drugs Control Organizations in India.

11) From technocrats to technomanagers: Realizing the need to equip the Drugs Control Officers with managerial skills, the AIDCOC decided to organize training programs on management issues. The AIDCOC retained the professional management consultant and formulated one-year training program module "Good Manufacturing Practices for the benefit of Drugs Control Officers in India". The module, which is of one year, includes eight days contact program and balance distance learning. So far, two batches of the officers have successfully completed the Good Manufacturing Practices training program and have received the certificates. The third batch is expected to commence in September 2006.

The AIDCOC also organized two days workshop on Good Manufacturing Practices, Nagpur in which hundred drugs control officers and the middle level executives working in pharmaceutical industry from Vidharbha region of Maharashtra.

12) Improving Investigational Skills of Drugs Control Officers: The AIDCOC efforts on training fronts were recognized by the Government of India by requesting Commissioner, FDA to associate AIDCOC in designing and implementing the training module on Improving Investigational Skills. Accordingly, the AIDCOC played important role in designing the training module and assisted FDA, Maharashtra to organize two training programs at Mumbai in 2003 and 2004. The AIDCOC also organized two days workshop on the Improving Investigational Skill at Chennai on 3rd and 4th April 2004. The workshop was organized in collaboration with CDSCO South Zone and was inaugurated by Smt. Supriya Sahu, lAS, Joint Secretary, and Ministry of Health and Family Welfare, Government of Tamil Nadu. About two hundred officers from South Zone participated in the workshop in which presentations on legal issues, intricacies of investigations and case studies were presented.

Success Stories

a) Appointment of Technically Qualified person as Head of the Department: AIDCOC's priority agenda of having technically qualified person as Head of the Department has been pursued consistently. AIDCOC has provided necessary assistance to the State Associations in their struggle on this point, The joint efforts of Technical Officers' Association, West Bengal and AIDCOC have yielded positive results. Consequent to the directives issued by the Kolkata High Court, the Government of West Bengal appointed a technically qualified person as the Director Drugs Control, West Bengal. Similar directives were issued by the Delhi Tribunal and the Union Public Service Commission selected a technically qualified person for appointment to the post of Drugs Controller, Delhi Administration. The Karnataka High Court, while disposing off the petition field to challenge the appointment of an IPS officer as Drugs Controller, Karnataka quashed the appointment of an IPS officer. The Government of Karnataka has now appointed a technically qualified person as the Drugs Controller, Karnataka State in accordance with the directives of High Court.

b) Change in Designation of Drugs Inspector: As a result of representatives submitted by the AIDCOC, a sub-committee of DCC was constituted to examine the issue. Taking clue from these developments, the Rajasthan Drugs Control Officers’ Association took up the issue with the Government of Rajasthan and succeeded in getting the designation of Drugs Inspector changed to the Drugs Control Officer. Based on the Government of Rajasthan decision, the AIDCOC is following up the issue with State Governments with the help of state associations so as to get similar decision from respective state governments.

Recognition of efforts

a) By Govt. of Inida: The efforts of AIDCOC on training front have been recognized. The committee, constituted for suggesting measures for curbing menace of spurious drugs under the Chairmanship of Dr. Agrawal, DGHS has recommended that the FDA Maharashtra should undertake training program on investigation skills for Drugs Inspectors. In this regard, the DCGI requested Commissioner, FDA to undertake this responsibility and in the same D.O. letter, the DCGI requested Commissioner, FDA to involve AIDCOC in designing and implementing training module.

b) By International Publishers: The international publishers have noted the activities of AIDCOC, especially on continuous education programs and the proposal of establishing training academy. The news on AIDCOC activities were covered by SCRIP, which is widely circulated International Pharma Publication. Other pharmaceutical journals have also taken a note of AIDCOC's activities and the training initiative of AIDCOC was appreciated in the editorial.

c) By Govt. of Bihar: As a part of AIDCOC's strategy of achieving professional excellence through self Initiative AIDCOC has designed a specific training modu e on "Improving Investigational skill of Drugs Control Officers" and implemented it through training programs and workshops. Recognizing these efforts, Administrative Training Institute, Patna, Govt. of Bihar, invited AIDCOC to impart training to newly appointed Drugs Inspectors. Accordingly, the President, AIDCOC accompanied by other members of AIDCOC camped at Patna for three days to train the Drugs Inspectors on various aspects of investigations, court procedure etc.

Consumer Education through direct action

AIDCOC decided to focus on direct action as regards to consumer welfare, especially, improving access to medicine. AIDCOC resolved to focus on direct action by going directly to the consumer with a view to educate them on their rights, brief them about the factual position vis-a-vis claims made about spurious drugs in India, to educate them about rational use of medicine and care to be taken to prevent abuse of medicine. As a part of this program, AIDCOC has issued pamphlets incorporating do's and don'ts to the consumers. Similar steps are also taken by other State Associations. AIDCOC also propose to put up hoarding in metro cities at prominent places to disseminate useful information to the consumer. As a part of this campaign, AIDCOC has organized various programs

a) Awareness on spurious drugs: A panel discussion on "Awareness on spurious drugs" was organized on 26th December 2004 at Vishakhapattanam on the occasion of National Consumer Week. During this panel discussion, the factual position as regards to percentage of spurious drugs and the inadequacies in Drugs Control Organizations was highlighted. The representatives from consumer organizations participated in panel discussion and welcomed the initiatives taken by AIDCOC. AIDCOC also organized a program on Awareness against spurious drugs and empowerment of consumers through 'e governance' at Vijayawada on 1]11'March 2005, as a part of World Consumer Rights Week. AIDCOC organized a motor rally on 16/07/2006 at Eluru, as a part of the State Governments Aids Awareness Initiatives.

b) Highlighting Role of regulatory officers in health care: AIDCOC organized a panel discussion on the theme "Role of regulatory officers in health care" during the annual Convention e d at Delhi on 10th October 2004. The experts from Pharmaceutical Industry, Community Pharmacy, Hospital Pharmacy and Regulatory Agencies participated in the panel discussion along with a representative from Consumer Coordination Council, New Delhi. The panel discussion enabled AIDCOCto project a factual image of the Drugs Control Officers and has resulted in a better coordination between the Drugs Control Officers and the stakeholders including the consumers.

c) Providing support to other organizations: AIDCOC provided a support to the Chemistsand Druggists Association in their initiative of establishing drug information and chemists' training center. The center has been established with a view to educate chemist in the district and to provide necessary information to the consumer on a various aspects of drug safety and its rational use.

d) National project on consumer awareness: The national project on consumer awareness was formally launched at the inaugural function held at Vishakhapatnamon 18/11/2005. The AIDCOC has undertaken the project in pursuance of the resolution passed during the Executive Committee Meeting held at Vishakhapatnam and the resolution passed during the 8th Annual Convention of AIDCOC held at Delhi in October 2004. The national project envisages the campaign on educating consumers on drugs safety and rational use of medicines through following methodologies:

i. Display Boards in all the medical stores advising the consumer to follow certain guidelines while purchasing medicines.
ii. Display of hoarding about usage of medicines.
iii. Produce documentary film on consumer education on medicines.
iv. Education of school children (8th to 10th class) on medicines usage and abuse of certain drugs.
v. Publishing handbills.

During the inaugural function, display boards were handed over to the senior chemists and the representatives of the chemists Association. As a follow up action, the 80% chemist's shops in coastal districts of Andhra Pradesh have been provided with such boards and they are displayed in the shop. AIDCOC is planning to implement the project in every state through affiliated State Associations.

Grievances redressal and efforts to ensure rational policy on critical issues affecting regulatory environment in the country Uniform organizational structure, uniform Status and pay scales for the Drugs Control Officers throughout the country and strengthening Drugs Control Organizations in India with a view to provide better services to the consumer are the priority objectives of the AIDCOC. The AIDCOC has been trying to achieve these objectives by apprising the authorities at central and state level through personal meetings and written representations, through press conferences and by providing inputs to the committees constituted by the Government of India and the State Governments.

a) Meeting with the Minister: The representatives of AIDCOC met the Hon. Minister for Health and Family Welfare, Government of India on number of occasions. The AIDCOC submitted first elaborate representation to the Hon. Union Health Minister at Hyderabad on 9th December 1997. As a follow up action, another representation wassubmitted to the Union Health Minister at Mumbai on 27/05/1998.

b) Meeting with the Joint Parliamentary Sub Committee: The representatives of AIDCOC met joint Parliamentary sub Committee on drug control at Hyderabad on 18/10/1997 and submitted a written representation highlighting inadequacies in the Drugs Control Organization.

c) Efforts for compliance of Rule 49: The AIDCOC effectively opposed the appointment of non-pharmacy graduates to the post of Drugs Inspector by the Government of Andhra Pradesh. This was done through the written representation submitted to the Government of India, by apprising the Health Minister about the provisions of Rule 49 and 49A of the Drugs and Cosmetics Rules, 1945 and by creating a public opinion through press conference.

d) Seeking Judicial Intervention: Consequent to the resolution passed by AIDCOC at Jalpaidgudi during the meeting of North East Zone officers, the AIDCOC filed petition in Supreme Court seeking directions for strict implementation of Rule49 and 49A 50 and strengthening the Drugs Control Organizations in India in accordance with the scheme submitted by the Government of India along with its affidavit filed in the public interest litigation filed by common cause society. The AIDCOC brought to the notice of the Supreme Court that nothing substantial has been done by the Govt. of India inspite of the specific directives issued by the Supreme Court. The petition was not admitted by the Supreme Court on technical ground. The AIDCOC now propose to file proper petition seeking appropriate directions from the Supreme Court.

e) Seeking implementation of Judicial Directions: On being requested by the Drugs Inspectors' Association, Uttar Pradesh AIDCOC submitted a representation to the Principal Secretary, Department of Health, Uttar Pradesh requesting him to appoint duly qualified persons as the licensing authorities in accordance with the directions issued by the Allahabad High Court.

f) Request for corrective measures on unfair amendment: The AIDCOC submitted representation strongly objecting to the amendment to the qualification for licensing authority for grant of manufacturing licenses for ayurvedic drugs effected under GSR 76/E dated 03/02/2003. AIDCOC specifically brought to the notice of the Government of India that the amendment, which disqualifies existing licensing authorities holding degree in pharmacy and issued without consulting the Ayurvedic Drug Technical Advisory Board, is not fair and good in law. Based on this representation, the Commissioner, FDA, Maharashtra also took up the matter with the Secretary, ISM and requested him to review the notification.

g) Inputs provided to Dr. Mashelkar Committee: AIDCOC requested the Government of India to co-opt member of AIDCOC in the Committee constituted by the Government of India to suggest measures to tackle menace of the spurious drugs. However, the Government of India did not respond to this request and therefore AIDCOC submitted exhaustive representation to the Committee on the same day highlighting the need to strengthen the Drugs Control Organizations, the need to establish intelligence branch at Central and State level with independent police help etc. While placing on record its opposition to the proposal of Central Licensing, the AIDCOC suggested various measures to ensure uniformity in implementation. The Committee also did not take a note of the representation made by AIDCOC, however, it was required to do so in view of persistent efforts made by AIDCOC and the public opinion in favour of AIDCOCs view created through the press conference organized by AIDCOC.

The Committee finally invited the representative of AIDCOC to make a presentation and accordingly the Secretary General made an elaborate presentation before the Committee. However, the subsequent events and submitting a final report by the Committee indicated a predetermined approach of the Committee. Therefore, the representatives of AIDCOC met the Hon. Minister for Health and Family Welfare, Government of India on 01/11/2003 and apprised her about AIDCOC's perception about the predetermined approach of the Committee. The written representation was also submitted to the Hon’ Minister.

h) Follow up action: The office bearers of AIDCOC me Smt. P. Laxmi, the Hon. State Minister for Health and Family Welfare on 14/08/2004 and 06/09/2004 objecting to the proposal to enlarge scope of Central Licenses Approving Authority by passing the recommendations of Dr. Mashelkar Committee. The written representation was also submitted to bring on record once again AIDCOC's opposition and undesirability of proposal of Central Licensing, Central License Approving Authority and the need to strengthen the Drugs Control Organizations in India.

i) Reacting to adverse publicity: AIDCOC strongly reacted to the adverse comments made in Telegraph and other publication. The AIDCOC also briefed the press, public, the senior officials and elected representatives about the baseless propaganda made by the India Pharmaceutical Alliance, CII as regards the percentage of spurious drugs available in the market.

j) Reacting to adverse recommendations: The AIDCOC submitted elaborate representation to the Government of India to oppose the recommendation of Joint Parliamentary Committee about amendment to the Drugs and Cosmetics Rules, 1945 to allow non-qualified person to dispense medicine. The AIDCOC also supported other professional bodies on this issue. The concerted and Joint efforts of AIDCOC, IPA, IPGA, IHPA and APTI ultimately compelled the Government of India to reject the recommendation.

k) Sensitizing the authorities: The President AIDCOC made presentation at the valedictory function of Indian Pharmaceutical Congress at Kolkata. AIDCOC views on the measures for the tackling the menace of spurious drugs, the need to strengthen Drugs Control Organizations opposition to Central Licensing were effectively presented before the Hon’ Union Minister for Health and Family Welfare.

l) Action on advertisement inconsistent with Rule 49(A) and SO(A): The AIDCOC submitted a representation to the Govt. of India and the Union Public Service Commission about the anomalies as regards to qualification in the advertisement issued for appointment to the post of Drugs Controller General India. It has been brought to the notice of the Government that the advertisement is inconsistent with the provisions of Rule 49(A) and 50(A) of Drugs and Cosmetics Rules, 1945 and therefore the post should not be filled in on the basis of such advertisement. The AIDCOC has requested the Govt. of India that the post of the Drugs Controller General India must be filled by appointing a person possessing qualification as prescribed under Rule 49(A) and 50(A). The AIDCOC has also decided to approach the appropriate court if the Government of India does not respect the provisions of Rule 40(A) and 50(A) of the Drugs and Cosmetics Rules, 1945.

Initiatives for amendment to constitution of IPCA

Consequent to the issues raised by AIDCOC, IPGA, APTI and IHPA, the committee was constituted to consider amendments to the constitution of IPCA. The committee submitted its report on 26/03/2005, however, the report did not resolve the issues debated during the meetings of the Review Committee and Council Meetings of IPCA. Therefore, the AIDCOC and above said federating bodies did not accept the report. Being aggrieved by the unresolved issues, the AIDCOC, APTI, IHPA and IPGA held joint meeting at Mumbai on 22/04/2005. The joint communication requesting for resolving the issues considered necessary for restoring democratic functioning in IPCA was addressed to the President IPCA. The matter was discussed in the Council meeting of IPCA and it was decided during the meeting that the President, IPA and President, AIDCOC would discuss the issue with a view to find a solution to the problems. During the meetings between President, IPA and President AIDCOC, certain proposals were discussed, however, IPA did not change its stand on equal voting rights. Subsequently, during IPCA's statutory meeting held at Hyderabad, It was decided that 58th IPC would be held at Mumbai by IPA jointly with AIDCOC, APTI, IPGA and IHPA. However, MOU to be signed is yet to be finalized in view of IPA's insistence of linking the MOU with the issue of equal voting rights.