“Our regular interaction has led to industry- friendly steps initiated by the Government”

Daara B Patel,
Secretary-General, IDMA.
"A more proactive interaction between enforcement agencies and stakeholders such as Industry, trade, chemists and doctors on a regular basis is missing and this would help in recognising early trends of drug abuse and putting in control mechanisms to prevent the same", says Daara B Patel, Secretary-General, IDMA. In an exclusive interview with Mahesh Kallayil, he elucidates the inaccurate information surrounding Ephedrine and Pseudoephedrine and NDPS (Narcotic Drugs and Psychotropic Substances).

Please brief us about the organizational set up of the IDMA? What are the major functions of IDMA?
IDMA has over 900 members from large, medium and small pharmaceutical & bulk drug manufacturers spread all over India. The administration of IDMA, headquartered in Mumbai, is vested in the Executive Committee headed by the National President, Hon.General Secretary and other Office Bearers. These Office-bearers and 15 Members are elected for a twoyear term by the Members of the Association. The Executive Committee also includes Past-Presidents, Corporate Members, Chairmen and Secretaries of State Boards and other invited Members. There are, at present, eight State Boards taking care of local issues on behalf of our Members in Gujarat, West Bengal, Tamil Nadu (including Puducherry and Kerala), Telengana, Karnataka, Himachal Pradesh & Uttarakhand, Haryana and Madhya Pradesh.

With the Executive Committee and supported by 20 Committees, headed by domain experts, IDMA works with the Government on the industry's development plans and various strategic matters and actively represents the industry on important issues such as Patents, Pricing, Regulatory and other policy matters and plays a crucial role in keeping opinion leaders, Press and public informed about the industry issues. We keep Members updated on all issues through regular email circulars & advisories, our weekly communication medium IDMA Bulletin, in its 47th year and our publicly accessible dedicated website www.idma-assn.org We also publish a monthly scientific and technical journal Indian Drugs, which is in its 53rd year and has a dedicated portal www.indiandrugsonline.org

Could you throw some light on IDMA's association with domestic and international organizations and how these collaborations helped to spruce up the growth of the pharma industry in the country?
IDMA is consulted by all concerned ministries & departments such as Health, Commerce, Finance, DOP, NPPA, DCGI etc in policy matters and revisions of rules and regulations concerning Pharma Industry. Timely and effective representations to the various Ministries and Departments for quick resolutions of issues is one of our main strengths. IDMA is recognised as the 'Voice of the National Sector'

We have signed MOUs with China Pharmaceutical Industry Association (CPIA), Korea Pharmaceutical Industry Association(KPMA), DuBiotech, Association of Biotechnology Led Enterprises(ABLE),Toyoma Pharmaceutical Association (TPA) etc. We are also in the process of finalising MoUs with British Generic Manufacturers Association and ProGenéricos of Brazil.

IDMA has always been proactive especially regarding pricing policy of drugs. We have worked with the Government to move from the restrictive cost based pricing to market based pricing and have been in continuous dialogue with the Government to ensure a fair price to consumers as well as industry.

IDMA was closely involved with Government in enacting our landmark Patent Act in 1970 that ensured patient-friendly laws at the same time supported manufacturers. Our regular interaction has led to industryfriendly steps initiated by the Government on delicensing and de-reservation, have enabled the Indian Pharmaceutical Industry to record virtually unmatched growth in the annals of Indian industry - or the pharma industry of any other country. From being an importer of medicines a few decades ago, today India exports to all countries in the world and is recognised as the 'Pharmacy of the Developing World'

Earlier this month, Thane police has arrested Avon Lifescience Director Manoj Jain in connection with the recovery of a major haul of ephedrine, pegged at Rs 2000 crore. May we have your comment on this ?
Avon Life Sciences has been involved in the manufacture of Ephedrine for more than a decade and has a URN (Unique Registration number) number with Narcotics Control Board. As per newspaper reports, d-Ephedrine, a by-product was seized from Avon's premises. There is no commercial value for this by -product. A detailed note on Ephedrine and Pseudoephedrine is attached, herewith. However, Avon is not an IDMA member and we don't have any further comments on this.

How profound is the menace of drug abuse mafia in India?
There is no confirmed data about the extent of drug abuse in India. However, as per INCB (International Narcotics Control Board) data, the percentage of seizures of prescription drugs by Indian enforcement authorities is negligible compared to the legitimate production and sales in the country. For eg, in 2013, the total Codeine cough syrups seized is 0.0186 percent of the total legitimate production in the Country. Similar is the case, with other prescription products.

Prescribed drugs like Opioid sand CNS depressants are often abused for its stimulant qualities. As a patron of pharmaceutical industry, how IDMA going to deal this issue?
Only 1 percent of terminally ill cancer patients receive Opioids such as Morphine for pain management. Other critical Opioids are not available for Indian patients due to complex regulatory hurdles. So, there is no case of abuse of prescription Opioids in India. With regards to CNS depressants, the only way forward is proactive interaction between enforcement agencies- Industry/Trade and devising appropriate mechanisms to mitigate the problem of abuse of CNS depressants. IDMA is working with enforcement agencies to build formal interactive programs and sensitize it's members on this subject .

What should be the right approach of the government in curbing the menace of prescribed drug abuse?
Prescription drug abuse menace is a world wide problem and not unique to India. It is pertinent to recognize the problem and Government of India policies should ensure availability of these critical medicines and at the same time mitigate the problem of abuse. It's easier said than done but the current approach of banning substances or harass legitimate manufacturers, traders, chemists and doctors does not serve the cause of availability of these medicines for needy patients. The right approach is that Department of Revenue (Ministry of Finance), the nodal agency for policy making and NDPS Act, consider amending the Act and designate a Specialised Single Nodal Agency for licensing, control and enforcement of legitimate NDPS and also form a Department of Narcotics to have a better focus on control mechanisms and at the same time, ensure access of medicines to patients. There is a NDPS Policy released by Government of India in 2012 but there is lack of a cohesive implementation and focus on this important subject, as there is no single nodal department or ministry responsible for this space. A more proactive interaction between enforcement agencies and stakeholders such as Industry, trade, chemists and doctors on a regular basis is missing and this would help in recognising early trends of abuse and putting in control mechanisms to prevent the same. Demand reduction in terms of treating drug addicts and appropriate counselling is non-existent in India. Though the Ministry of Social welfare and Justice is mandated to undertake demand reduction and has policies in place, this exists only on paper.

Over the past several years, what are some of the trends that you've noticed in the industry, and how has IDMA responded to these changes ?
The Narcotic Drugs and Psychotropic Substances(NDPS) Act and penal provisions have been designed to prevent and combat illicit trafficking and is draconian and harsh. The penalty for even procedural or inadvertent lapses for Industry is a minimum of 10 years and upto 20 years. As a result, these draconian provisions have been the cause of harassment to Industry, trade and medical community. Large Indian companies are exiting manufacture of Psychotropic (CNS), narcotics and controlled substances and so are the dealers, chemists and doctors. For eg., Products such as Ephedrine and Pseudoephedrine, which had more than 100 MT sale per annum in India and bigbrands such as Action 500, Actifed Plus, Coldarin D, D-Cold had these as their main ingredients, have exited these products and the current demand is less than 5 MT per annum. However, India exports more than 50 percent of the world Ephedrine and Pseudoephedrine requirements. This is the trend in most of the substances in the NDPS category. IDMA has been working with the Department of Revenue in amending the Act to address the issue of harassment of legitimate manufacturers and ensure availability of NDPS medicines for needy patients. Several representations and meeting have been held since 2011 and IDMA has been in the forefront to mitigate the trend of increasing non-availability of these medicines for the Indian patients and at the same time, working with the Government/enforcement agencies to mitigate drug abuse problem.

What are the current biggest challenges ahead and how are you gearing up?
Multiple agencies enforcing the NDPS Act and harassment under the disguise of the NDPS Act are the biggest challenges faced by Industry, Trade and medical community dealing with NDPS. IDMA has been in the forefront of advocacy with the Department of Revenue in amending the NDPS Act in having a Specialised Single nodal agency to issue licenses, monitor and enforce the NDPS Act for legitimate entities, amend Sections 35, 41 & 42 to address harassment and introduce compounding of offences for inadvertent and procedural lapses.