My short sojourn to Mexico - the land of Mayan Civilization

It is said, “journeys help you discover your true inner self”. My third visit abroad to Mexico to attend 12^th annual conference of the International Society of Pharmacovigilance at Cancun was not as smooth and hassle-free as my earlier two trips to Turkey and Australia but it helped me have a glimpse of the resolute self inside me. This time I was going to present a couple of my accepted research papers at the conference that was scheduled to be held between October 30^th to November 2^nd, 2012 at Hotel J. W. Marriott, Cancun, Mexico – the land of Mayan civilization.  

Air travel:

I commenced my journey from Srinagar and my first stop-over was at Delhi followed by Mumbai. Upon reaching Mumbai while I was marching ahead to go through immigration clearance and catch my next flight to New York I got the shocker that all flights to New York have been cancelled owing to the threat of hurricane Sandy looming large over the East Coast of USA. The queue of affected passengers was horribly long and after a wait of over three hours in the queue I could make up to the airlines counter where I was offered a refund in case I opted to abandon my trip. But in spite of the apprehensions of getting stranded somewhere in Europe or America, I chose to go by some alternative route. I was reminded of an anonymous quote, “If you don’t get lost, there’s a chance you may never be found.” They offered me a route in which I had to change four planes from Mumbai to London to Houston to Mexico City to Cancun and my original journey of 21 hours was getting overstretched to more than 48 hours. I accepted their offer and boarded my flight with words of Alex Noble reverberating in my mind, “Success is not a place at which one arrives but rather the spirit with which one undertakes and continues the journey.”   

Decorated Christmas tree at London Heathrow airport

Upon arriving at London Heathrow airport, it was cold and raining. I rang up to my home to inform them about the changed schedule. London Heathrow was a very busy airport and after we landed I could see at least seven planes lined up in the air waiting for their turn to land. Before our landing we circled many times over London and in the process we could have a detailed glimpse of the London city from air. My next stop was Houston, from where I flew to Mexico city. After going through my immigration clearance at Mexico City, I reported at the ticket counter 45 minutes before my next connecting flight. Travel agent shocked me by saying that check in closes one hour before the actual flight and therefore I won’t be able to check myself in. I had to catch the air train and rush back to the International terminal to contact my airlines agent for the next flight. To my surprise in the entire hall of more than 20 ticket counters, not even a single counter was operative. On top of it no Adam or Eve around was able to speak or understand even a single word in English. After great difficulty I could locate a person for claiming my baggage and he generated a printed ticket for me from his computer and told me to rush back to domestic terminal for catching the next flight to Cancun scheduled at 10 pm. This time air train was very cruel on me since it was arriving to pick me up only after a gap of 15 minutes which I was not in a position to afford since it was already 9 pm and I had to check in immediately. Somehow I reached the check in counter and they checked me in at the eleventh hour and I boarded my sixth and last flight to Cancun. However all miseries were not over for me yet. Upon reaching Cancun I received another blow when I was told that my baggage has not arrived and will be delivered later at my hotel. Consequently I had to spend the first day of the conference uneasily in my travel attire. However my room-mate Raul Rodriguez Ramos, a Mexican Pharmacovigilance student from Guadalajara was kind and sweet enough to lend me his razor so that I could shave my beard off. Early morning when I stepped out onto my hotel room balcony, the sight in front of me was incredibly amazing. View of clean turquoise waters of Caribbean sea, tidy white sandy beaches and tall hotel buildings of Cancun standing in a row, was nothing short of some heavenly abode. All my travel miseries vanished in a jiffy and I found myself in an entirely different frame of mind.

Mexican people and their food:

Mexican vendors selling handicrafts at Chichen-Itza

Mexico became a nation in 1821 when it achieved independence from the Spanish empire that had gained control of Mexico after the conquest of the Aztec Empire in 1521 A.D by Spanish Conquistador. No surprises then that the most spoken language by Mexicans is Mexican Spanish. Very few of them speak English. Mexican Spanish is distinct in dialect, tone and syntax to the peninsular Spanish spoken in Spain. Mexico is the most populous Spanish-speaking country in the world with 17% of its population living below Mexico's own poverty line. According to the OECD, worldwide Mexico is the country with the second highest degree of economic disparity between the extremely poor and extremely rich, beaten only by Chile. That is probably why drug-trafficking and narco-related activities are a major concern there. Otherwise Mexican people are known for their kindness and hospitality. Descendants of the Aztecs and Mayas, they show great artistic skills as well as pride for their heritage. The vast majority of the population comprises of Roman Catholics, even though many have incorporated several of their ancient pagan deities and rituals quite similar to those of Indian Hindus into their local version of Catholicism. Majority of the Mexicans are slightly short, well-built, round faced people with short neck, dark eyes, stout nose, high cheek bones, epicanthic folds, jet black hair that is thick and straight and mostly turned upwards.

During lunch on the first day of the conference, we got a taste of the world famous Mexican cuisine, which, like Mexican people, is highly tied to the Mexican culture, social structure and its popular traditions. The basic staples remain the native corn, beans and chili peppers. While it is eaten fresh, most corn is dried, treated with lime and ground into a dough, which is then used fresh and fermented to make a wide variety of dishes from drinks (atole, pozol, etc) to tamales, to sopes and much more. However, the most common way to eat corn in Mexico is in the form of a tortilla, which accompanies almost every dish over there. Mexicans are very fond of Tequila, a distilled beverage made from the blue agave plant, often made at a 38–40% alcohol content. When served neat (without any additional ingredients), tequila is most often served in a narrow shot glass called a caballito that means "Little Horse" in Spanish.

Welcome reception and the Mariachi:

Mariachi singers performing during welcome reception

First day of the conference was dedicated to pre-conference workshop on Basics in Pharmacovigilance.  It was a great learning experience. In the evening welcome reception was hosted in the moonlit open air lawns of the conference venue. Highlight of the evening was musical performance by the Mexican folk singers called Mariachi. The word mariachi was thought to have been derived from the French word “mariage" (marriage) dating from the French intervention in Mexico in the 1860s, related to the music’s appearance at weddings. Mariachis wear the charro or traje de charro, which is a Mexican cowboy suit consisting of a waist-length jacket, bow tie, fitted pants, short boots and a wide-brimmed sombrero hat. The suits are elaborately decorated with silver or gold buttons and embroidered designs. Mariachi was recognized by UNESCO as part of the Intangible Cultural Heritage of Humanity in 2011. We thoroughly enjoyed the Mariachi performance and they filled the moonlit evening with warmth and ecstasy.

Salsa lessons for the Pharmacovigilants:

View of Cancun beach from my hotel balcony

On second day of the conference at Cancun (literally meaning nest of snakes) several reputed experts in Pharmacovigilance from various parts of the world spoke about diverse contemporary topics at length and discussed latest advancements in the field. It was an intellectually enriched and content-full day for the participants. Social programme arranged by the organizers for the second day evening was Salsa dancing lessons from a Cuban instructor. It was full of fun since many seniors with absolutely no dancing prowess were seen dancing like jumping-jacks on the Mexican tunes while trying to learn the salsa steps. It was a dance-with-no-barriers occasion, a good piece of entertainment for all.

Visit to Chichen Itza - ancient city of Mayan Civilization:

In front of the Temple of Kukulcan at Chichen Itza

On last day of the conference we stole some time out to visit Chichen Itza, a UNESCO world heritage site that figures among the new seven wonders of the world as elected on 07.07.2007. Number seven has a lasting spiritual association with this site. Chichen Itza is a Spanish word meaning “at the mouth of the well of the Itza". The archaeological site was a large pre-Columbian city built by the Maya civilization and is presently located in the Mexican state of Yucatán. The buildings of Chichen Itza are grouped in a series of architectonic sets, and the three best known of these complexes are the Great North Platform, Temple of Warriors and the Great Ball Court. Dominating the North Platform of Chichen Itza is the Temple of Kukulkan (a Maya feathered serpent deity), usually referred to as El Castillo ("the castle"). Every portion of the structure housing temple of Kukulkan (Mayan pyramid) represents some part of the Mayan calendar that had 18 months in a year of 20 days each and the remaining 5 days of the year having been considered by Mayas as inauspicious days when their gods would fight against the devils. Each of the temple’s four sides has its own stairway. When counting the 91 existing steps in each face, plus a central step that is on top of the building, you get 365 steps, the exact number of days in a year. This and many more details indicate the precision of the Maya with regards to the study of the sun, the moon, the planets and the stars. Mayans used to construct another temple over an already existing one every 54 years with similar shape and structure as the earlier one, leaving the previous one intact. A loud clap evokes different kinds of interesting reverberations at this point including bird sounds. On the spring and Autumn equinoxes, in the late afternoon, the northwest corner of the pyramid casts a series of triangular shadows against the western balustrade on the north side that evokes the appearance of a serpent wriggling down the staircase. During such times thousands of Mexicans throng this site to visualize the phenomenon.

Deadly Mayan Ballgame:

Live performance of the Mayan Ballgame by artists at Xcaret

There is a Great Ball Court about 150 metres to the north-west of the Castillo for playing the Mesoamerican ballgame, a game that is not played using hands or feet but in which solid balls made of rubber and weighing around 4 Kgs are pushed using only hips and struck into the stone ballcourt goals fixed at a height of around 5 meters. At the base of the high interior walls of the ball court are slanted benches with sculpted panels of teams of ball players. In one panel, one of the players has been decapitated; the wound emits streams of blood in the form of wriggling snakes. Decapitated player is the winning captain who has been sacrificed to please and invigorate the Mayan gods. This was the saddest part of the Mayan story that made us melancholic and depressed. Even more saddening was the fact that Mayan people used to sacrifice children in a nearby well called Cenote Sagrado during situations like drought to please their gods. The Tzompantli, or Skull Platform (Plataforma de los Cráneos), was the place where decapitated head of the winning captain would be erected over a stick until it turns into a skull. Chac-Mool is the name given to a type of Pre-Columbian Mesoamerican stone statue that depicts a human figure in a position of reclining with the head up and turned to one side, holding a tray over the stomach, believed to be used for human sacrifice by the Mayans. Behind the temple of Kukulcan is the temple of thousand pillars used by Mayans for trade, religious and social congregations. Visit to Chichen Itza is a historian’s dream and a common man’s delight.

Musical Show at Xcaret, Riviera Maya:

Dramatic depiction of conquest by Spanish conquistador

Social programme on the third day of the conference was arranged by the organizers at Xcaret, a majestic archaeological park located in Riviera Maya, Cancun in the Mexican Caribbean Sea shore where we enjoyed a show at night, with more than 300 actors on stage, resulting in a musical journey through the history of Mexico since pre-Hispanic times to the present day, with all the colourful costumes, folklore and dancing. Actors posing as inhabitants of the pre-Hispanic world greeted us with aromatic copal resin incense and the beating of drums. A nocturnal bird emerged from the darkness of a cave to tell its story in the form of a dance. Xcaret Park Riviera Maya presented a live performance of the Mayan ball game, a cosmic metaphor between warriors from heaven and the underworld.

Day of the Dead celebrations:

Beautifully coloured Katrina la Meurte

As in many Latin American countries, Mexico commemorates El Dia de los Muertos - the Day of the Dead or All Soul’s Day on November 2^nd, every year. Our visit to Xcaret coincided with the Day of the Dead celebrations there. The legacy of past civilizations is graphically manifested on this occasion through people’s beliefs that death is a transition from one life to another in different levels where communication exists between the living and the dead. Despite the morbid subject matter, this holiday is celebrated joyfully and the emphasis is on celebrating and honoring the lives of the deceased, rather than fearing evil or malevolent spirits. It is common practice to keep skulls known as “Katrina la Muerte” as trophies and display them during rituals to symbolize death and rebirth. On ‘Day of the Dead’, foods such as tamales and mole are set out on altars with lots of other eatable offerings and it is believed that the visiting dead relatives “eat” the “essence” of the food. If eaten afterwards by the living it is considered to be tasteless. Apart from the scintillating and mesmerizing musical and dramatic performances by folk artists inside Xcaret on the Day of the Dead that we enjoyed to the hilt while having cold drinks, dinner, desert etc right on our seats, whole ambience around Xcaret theatre that night was magical. Numerous stalls had been erected with people wearing ancient Mayan costumes, painting their faces like dead, singing, dramatizing, praying and offering eatables on altars. It was a different world altogether whose imprints will remind indelible on my mind for a long time to come.

 

Pre-Conference Workshop on "Basics in Pharmacovigilance" (October 30th, 2012) 

Presenting my poster on first day of the conference

Programme was very interesting as well as informative and quite useful presentations were made by some renowned experts in Pharmacovigilance like Ulrich Hagemann, Deirdre McCarthy, Saad Shakir, Marie Lindquist, Eugene Van Puijenbroek, Rachida Soulaymani, Souad Skalli, Nicholas Moore and Luis Alesso on various topics of Pharmacovigilance like Principles of risk management, ICH and CIOMS guidelines, Cohort event monitoring, Medication errors, Signal detection, Risk communication, Herbal Medicine Safety, Developments in Pharmacoepidemiology and Counterfeit medicines. All presentations of the course were followed by interactive sessions and the deliberations were quite stimulating. Whole course was organized well and conducted in a punctual manner. In nutshell it was a great learning experience wherein participants could update their knowledge and understanding about various issues pertaining to drug safety.

Main Conference:  (October 31^st to November 2^nd, 2012)



My oral presentation on third day of the conference

All sessions of the main conference attended by me were highly relevant to the contemporary issues in pharmacovigilance wherein erudite presentations were made by some reputed stalwarts in this field that provided me with a great opportunity to expose and update myself to the latest advancements and recent trends in drug safety and efficacy management. Greater emphasis was laid upon post-authorization safety and efficacy studies, impact of new EU post-licensing legislation on pharmacovigilance, pharmacovigilance in pediatrics, women and reproductive health, ecopharmacovigilance, pharmacovigilance in hospitals, communication in pharmacovigilance, signal detection and evaluation and upon regional and global developments in pharmacovigilance. Conference helped me to a great extent in deciding my future research goals and in propagating the renewed knowledge and experiences gained to my students, scholars and colleagues back in my own University. I look forward with keen interest to apply the methodologies and concepts shared through poster presentations of the conference back in my own local settings in days to come. It was a content-full and substantially enriched conference for me that will positively and considerably impact upon my regular teaching and research work back home.

Valediction of the Conference:



Tulum A: Main conference hall of the conference

My oral presentation was scheduled on the last day of the conference whereas I had presented my poster on the very first day. Both of my presentations were well received and I answered lot many questions. My return journey was quite pleasant in spite of being tiresome and well on time since the impact of hurricane Sandy had completely subsided by then and flights were operating as per schedule. It was a memorable trip to sum it all.

(Author is working as Senior Assistant Professor at the Department of Pharmaceutical Sciences, University of Kashmir and can be reached at ishaqgeer@gmail.com)

Improvements in drug policy of the Indian state of J&K through persistent advocacy and logical interventions by Civil Society Forum

FOLLOWING ADDITIONAL POLICY PROVISIONS WERE INCORPORATED BY GOVERNMENT OF THE INDIAN STATE OF JAMMU AND KASHMIR IN ITS MAIDEN DRAFT DRUG POLICY AS A RESULT OF PERSISTENT ADVOCACY, PERSUASIVE PRESSURE AND LOGICAL INTERVENTIONS MADE BY CIVIL SOCIETY FORUM OF KASHMIR:

1.    Updation of the essential drug list shall be carried out every two years for the public sector.

2.    Qualified pharmacists shall also be included in the State Drug Committee meant for preparing and updating the essential drugs list.

3.    Effects of local diseases, food habits on drug effectiveness (e.g., malnutrition, liver diseases etc.), local differences in sensitivity and resistance of micro-organisms and differences in climate, topography and other environmental factors shall be duly considered while selecting drugs for preparing essential drugs list.

4.    Proper re-call and disposal procedures shall be followed as per standard guidelines.

5.    Approved private sector laboratories under overall supervision of the State Government shall also be involved to ensure the quality of drugs in the State.

6.    Annual testing load and average testing time of existing Drug Testing Laboratories shall be fixed for proper accountability.

7.    Efforts will be made for accrediting the drug Testing Laboratories as per national standards.

8.    Efforts shall be made to strictly enforce the provisions of the J&K Pharmacy Act, Samvat 2011 and the rules framed thereunder.

9.    Regulatory laws related to quality control of AYUSH drugs shall be examined. Suitable amendments in the said regulations shall be made, wherever necessary.

10.The rules relating to cosmetics shall be enforced and laboratories notified for testing purposes.

11.Sale, Storage, use of drugs and record keeping specified under Schedule X of the Drugs and Cosmetics Act, 1940 shall be supervised and monitored effectively by the inspectorate working under Drug and Food Control Organization, J&K.

12.Special checking squads under the leadership of Deputy Controllers will be constituted to undertake periodic inspections in this regard.

13.Schedule-H drugs shall be strictly dispensed on the prescription of Registered Medical Practitioners.

14.An Intelligence-cum-Legal Cell shall be established in the office Drug and Food Control Organization, J&K to facilitate busting of spurious drug rackets and their prompt prosecution.

15.Efforts shall be made to provide incentives to informers giving information about spurious drugs.

16.Efforts shall be made to rationalize number of Drug licenses.

17.Clinical pharmacy services shall be introduced in all major Hospitals for the benefits of the patients.

18.Best practices will be followed in Blood Banking and Transfusion of Blood.

19.Efforts shall be made to strengthen the provisions of J&K Pharmacy Act Samvat 2011 and also enforce education regulations thereof.

 

FRESH INITIATIVES AND NOVEL APPROACHES REQUIRED IN THE FORMULATION OF STATE MEDICINES POLICIES WITHIN INDIA

INITIATIVES FOR CURBING THE MENACE OF SPURIOUS/COUNTERFEIT/SUB-STANDARD/MISBRANDED/ ADULTERATED DRUGS:

a.       Special courts should be designated to try the cases of spurious drugs.

b.      Creation of intelligence cum legal cell to facilitate busting of spurious drug rackets and their prompt prosecution respectively should receive thrust.

c.       Provision of secret funds and incentives to informers giving information about spurious drugs should be endeavoured.

d.      Effective networking system between neighbouring states should be developed.

e.       Necessary changes in law should be made to award severe and deterrent punishments as afforded under law to those dealing with spurious drugs, making the offences cognizable and non-bailable in the light of similar provisions in Narcotic Drugs and Psychotropic Substances Act.

f.       Proliferation of drug distribution outlets should not be encouraged. A distance of at least 500 meters should be maintained between two successive shops.

g.      Drug sale licences should be issued only to persons holding diploma or degree in pharmacy from a recognized/duly approved university/institution. Necessary amendments should be made in the relevant Acts to enforce this provision.

h.      Preparation of dossiers of suspected dealers and manufactures should be a perpetual exercise. Such dealers should be black-listed and their licences cancelled.

i.        Manufacturers should be encouraged to have their own anti-counterfeit drug strategies like RFID, QRC etc, better surveillance and efficient complaint handling system.

j.        A statewide survey should be conducted to measure the magnitude of spurious drug trade in the state, lifting samples from every nook and corner of the state in a statistically designed scientific manner.

k.      Effective interaction between the stakeholders i.e. industry and regulators, industry and consumers, trade and regulators and medical professional and regulators, should be developed

INITIATIVES IN RESPECT OF DRUGS BELONGING TO AYUSH SYSTEMS OF MEDICINE:

a.      A committee comprising of traditional health practitioners and healers, and experts in pharmacognosy, toxicology and related fields should be constituted to study and guide the various activities with respect to AYUSH drugs.

b.      The health conditions that can be treated with these traditional systems of medicine should be identified.

c.       An appropriate methodology and technology for the identification, development and production of medicinal items used by the traditional systems of medicine should be developed.

d.      Scientific studies to evaluate the quality, safety and efficacy of traditional and herbal medicines should be fostered and promoted.

e.      All practitioners of traditional medicine systems as well as the public should be encouraged to remain alert to adverse reactions to traditional and herbal medicines and to notify them to the Drug Information Centres and the nodal centre for drug information in the State.

f.        Cultivation and research of medicinal plants, should also be encouraged and promoted.

INITIATIVES FOR RATIONAL DRUG PROMOTIONAL PRACTICES:

a.      All drug promotional practices of pharmaceutical companies and prescribing practices of doctors should be in accordance with Dec.,2010 amendments of the MCI code of Medical Ethics (professional conduct, etiquette and ethics Regulations), 2002 and the prescribers should be made to adhere to these guidelines in letter and spirit.

b.      Authorities of government hospitals, particularly teaching hospitals, should ensure that medical and pharmaceutical sales representatives’ activities and conduct are in conformity with standard ethical norms and do not, in any way, hamper routine patient care. All sales representatives should be allotted a specified time and venue inside the hospital for detailing their products.

c.       Drug Policy should ensure rational prescribing practices by doctors, rational dispensing practices by pharmacists and rational use of medicines by the consumers in an integrated and seamless manner.

d.      Promotion-making claims of pharmaceutical suppliers should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste.

e.      Product information of all kinds, should be scientifically valid and evidence-based.

f.        Offering, soliciting or accepting inducements of any kind, monetary or material (except free samples of product in modest quantity) for promotional purpose should not be indulged in.

g.      Prescribing doctors or dispensing pharmacists should not accept support or assistance of any kind conditional upon obligation to promote a medicinal product.

h.     Professional societies, educational organizations may accept partial sponsorship from the pharmaceutical companies for holding scientific meetings and symposia, but this should be clearly stated at the meetings and in proceedings. Care should be taken to ensure that the sponsorship in no way affects the quality of scientific deliberations in the meeting.

INITIATIVES TO COUNTER THE MENACE OF DRUG ADDICTION AND SUBSTANCE ABUSE:

a.      Sale, storage and use of drugs specified under Schedule X of the Drugs and Cosmetics Act, 1940 should be regulated with a greater vigil by the inspectorate working under Drug and Food Control Organization, J&K. Proliferation of drug stores should be discouraged and easy availability of substances of abuse should be reversed.

b.   Record-keeping of such drugs should be made indispensable and the same should be checked regularly by the inspectorate. Special checking squads should be framed and authorized to undertake periodic necessary inspections in this regard along the length and breadth of the state.

c.   License to sell, stock and distribute drugs pertaining to Schedule X should be restricted to dealers with absolutely spotless track record and should not be issued to those indulging in any sort of unlawful activities.

d.   Workforce of the Narcotics Control Bureau should be augmented and its nodal centre established at Srinagar. 

e.   A multi-disciplinary Coordination Committee under the Chairmanship of Chief Secretary or a senior Secretary should be established for regular interaction with various Central and State agencies; to receive support and grant-in-aid assistance from Narcotics Control Bureau of India.

f.        The state should set up an Anti Narcotics Task Force under an IG level officer with duties and responsibilities duly demarcated.

INITIATIVES FOR RATIONAL BLOOD BANKING AND TRANSFUSION POLICY

a.      Procedures of blood banks e.g. blood collection, processing, compatibility testing, storage, component separation, transfusion of blood and blood products and all other related activities should be practised as per the rules and regulations under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 and in accordance with relevant statutory guidelines.

b.      In keeping with the constant needs and constraints, special provisions should be made to facilitate availability of blood and blood products through a substitute storage system, in peripheral areas where good blood banking system is still in the process of development.

c.       An expert Committee shall devise Standard Operating Procedures and oversee the functioning of all blood banks and peripheral storage facilities to ensure and facilitate the above goals.

INITIATIVES FOR PHARMACY EDUCATION REGULATION POLICY

a.      For this purpose central Pharmacy Act of 1948 should be enforced in the state to replace J&K Pharmacy Act 2011 (samvat) and the J&K Pharmacy Council should endeavour to constitute its executive committee and frame Pharmacy Education Regulations and implement them as soon as possible so that minimum standards can be prescribed for colleges and institutes offering diploma or degree courses in Pharmacy.

b.      This will make sure that nobody enters the profession of pharmacy without earning a legal qualification. Further the constitution and scope of J&K Pharmacy Council should be broadened, making it all-inclusive by enrolling professionals from academia, hospitals, industry and trade as its members.

INITIATIVES FOR DRUG SAFETY MONITORING POLICY

a.      Although medicines are useful to alleviate human illness, all medicines are not completely safe. Therefore, pharmacovigilance is necessary to safeguard the public from the possible adverse drug reactions and prevent the cause of false public alarm and misinterpretation. Pharmacovigilance activities should be funded through the State drug budget.

b.      Pharmacovigilance centres should be established to monitor and document adverse drug reactions and events.  These centres should collect data on adverse reactions and events and other drug related problems like substandard drugs, counterfeit drugs, inappropriate use, medication errors etc. from various health professionals/workers.

c.       Pharmacovigilance centres should also be established under the national Pharmacovigilance Programme of India in all hospitals of the state.

d.      Measures should be taken to enhance spontaneous reporting of adverse drug reactions in all hospitals of the state.

e.      All adverse drug reaction reports and other drug related problems should be properly documented and follow up action including preventive measures shall be taken.

f.        Besides Pharmacovigilance, other clinical pharmacy services including Pharmaceutical Care Services, Drug Utilization Studies, Therapeutic Drug Monitoring, Patient Counseling, Evaluation of Prescribing Practices, Pharmaco-economics & Cost analysis and Pharmacy Practice divisions should be established in all hospitals.

INITIATIVES FOR DRUG LICENSING POLICY

In order to control mushrooming of retail shops in urban areas at least 500 meters distance to be kept between two shops. Stringent norms should be followed with regard to service of Pharmacists, storage & issuing of cash memos.

INITIATIVES FOR DRUG INFORMATION POLICY

a.      All potential and actual users of medicines must have ready and meaningful access to scientific, truthful, unbiased, evidence based and independent drug information.

b.      Drug Information Dissemination Centres (DIDC) must be established in all major hospitals of the state.

c.       The Nodal Centre should collate all current information on drug use and disseminate them appropriately to all potential users in general and the prescribers in particular, towards the promotion of RUD.

d.      The feasibility and prospect of collaborating with NGOs in the State, working in this area should be explored.

e.      A Committee with the representatives from Drugs Control Authority, Health Administration, Drug Seller's Association, Consumers and Academia, must oversee and monitor the functioning of the DIDC and suggest changes, if and as necessary.

INITIATIVES FOR LOCAL (STATE LEVEL) DRUG INDUSTRIAL POLICY

a.      Development of Pharmaceutical manufacturing Industry/Pharma Zone within the state by providing capacity building, soft loans, subsidies and special exemptions

b.      To attract pharmaceutical formulation and bulk drug manufacturers to set up plants at an area which is easily accessible will be provided for developing an upgraded Pharma zone / city.

c.       The govt. of J&K must consider providing the following facilities:

Ø    Sufficient and uninterrupted supply of electricity

Ø    Common effluent treatment plant

Ø    Single window system

Ø    A liaison officer to co-ordinate between industry and govt.

Ø    Provision for low cost land and relaxation of tax and duties

Ø    Special packages for encouraging NRK investors

Ø    Soft loan to encourage R & D

Ø    Subsidy for modernisation of existing facilities.