Emergency Contraceptive: The fallacy is crafting a threat to the motherhood! Ambiguity in the Drugs act should be rectified and redefined!

Oxford dictionary has defined the word ‘Emergency’ as a sudden state of danger, conflict, etc. requiring immediate actions to restrict, prevent or control over the prevailing condition. Henceforth the fraction of time is more important than the moment or state of the situation. Sorbitrate should be placed at the beneath of the tongue while chest pain is suspected, Alupent must be applied to patients having gradual fall at blood-pressure. In all such cases we find no instructions from the manufacturer or the doctors to recommend time limit even within 72 minutes but to apply at once.

Contraceptive means a method to prevent or elude conception or pregnancy. It is expected that the conscious couple shall arrange precautionary measures available in the market before they turned crazy in the dim light. Gynecologists prefer counseling to provide the best advice to the conjugal duo for maintaining safety at the time of sex, considering any obstacles or hindrances may cause anxiety. Yet the entire brand of Emergency Contraceptive Pills in India or “E.C.P” is doing a business of more than 300 million per year through confusing and ambiguous advertisements both through print and electronic media.

After 63 years of independence in our country our administration still import ideas, conceptions in stead of invent innovative and exclusive brainstorm. Reintroduction of “E.C.P.” as O.T.C (Over The Counter) Brand in India after their fumbled movement through regular prescriptions implies that though the doctors were not convinced with the efficacy of the drug called “Levonorgestrel” but the Central Drugs Standard Control Organization (C.D.S.C.O) or Drug Controller General of India (D.C.G.I) or Drug Technical Advisory Board (D.T.A.B) approved the brands without considering the adversities and contradictions of the medicine on human health in India. It is apprehended that DTAB is not well-equipped to challenge or combat the endorsements of the regularity committee of US FDA.

India is the paradise for the Pharmaceutical manufacturers having formulations of irrationally combined drugs. Deanxit, the psychotropic drug shirked the mandatory clearance of DCGI as it required no clinical trials though DTAB was aware enough that “melitracen” is a banned drug even in the country. Companies marketing E.C.Ps perhaps had analogous advantages as C.D.S.C.O believes in that the people of the ‘Land of Shiva” can even digest ‘Poison’ understanding medicines is always an ambrosia to them.

We understand ECPs are brands like I-Pill (Cipla), Norlevo (Win Medicare), EC-2 (Zydus), Unwanted-72 (Mankind) but the first brand introduced and promoted in our country was Pill-72 by Cipla at least 7-8 years back. It was mandatory for the physicians to maintain the database and clinical records of the patients on whom the medicine has been applied. The dosage was to have 2 tablets within a period of maximum 12 hours. It was printed in the prospectus of the medicine enclosed with the pack that sense of vomiting or lower abdomen pain of the users of such medicines defiantly invites the visit and immediate diagnosis of the prescribing doctors.

In the year 2006 US FDA fastened the regulation of the usage of ECPs through prescriptions of the doctors introducing specific clauses. As per Federal Legislation, HR-926 school students were not entitled to buy ECPs, but girls below 17 years old got the recent sanction to purchase such brands only against valid prescriptions. In a report published on 01st November 2009, 7 states including California, New Mexico allow pharmacists to distribute ECPs when acting under the collaborative-practice agreement with a physician. Only 3 states direct pharmacists to fill all the valid prescriptions to comply with the expanding access of using ECPs in America. On the other hand 8 states including Georgia, Mississippi, Arkansas have adopted restrictions on ECPs. Surprisingly 2 state legislatures exclude ECPs fro their contraceptive coverage mandate. US FDA has mandate to use ECPs only to the sexually assaulted women at most parts even after directing to provide exclusive rooms at hospitals to provide service and relevant counseling.

In USA, a prolonged tussle between the ‘Pro-Life’ group and the Liberals” generated confusion on current definition of “Pregnancy”. Pro-life groups define that the life of a human being as starting at the instant of conception. Robert Maginnis, the vice president of Family Research council describes that usage of ECPs kill human embryo. In 1997, February 25th, Christian Medical & Dental Society of Bristol released a press note that ECPs generally abort a pregnancy. Approving and promoting such ECPs is medically irresponsible therapy. They claimed to emphasize more on sexual responsibilities. The Fellow of the Royal College suggests that a pre-embryo (a fertilized ovum which has not implanted in the wall of the uterus) as an entity lacking in rights, considering the public might be more willing to allow the use of stem cells extracted from those pre-embryos for scientific research or as a subject for genetic screening.

Today American College of Obstetricians & Gynecologists, U S Dept of Health & Human Services and Us FDA endorsed the term Pregnancy as a state generates only after implantation in the uterine lining. Simultaneously US FDA also follows this definition in its approval process for applying ECPs and states that individuals may have varying the definition of when the pregnancy begins. Such confusing conclusion provides opportunity to the Indian Pharmaceutical companies to market ECPs through advertisement keeping several fallacies at their prospectuses and literatures.

We Indians belong to a country where rich culture and heritage prevails as moral standing. The real reasons for this apparent decline in morality in our society lie elsewhere: rapid urbanization, improper education, the desire to adopt anything Western - the list is endless. Dr. Sujata Singhi of AIIMS demanded that easy access to emergency contraception gives an extra mile of confidence to adolescents and encourages slip into the immoral act as Indian have lack of will power and moral strength, lack of adult role models and sexual exploitation of the young, mostly by the mass media and industries. At this juncture easy access of ECPs can only encourage social calamity. Dr. K.M. Kapoor at Fortis explodes with a fact that the demand for ‘revirgination’ at a cost of Rs. 25000- Rs. 30000 among the unmarried girls have been increased causing parallel demand of hymenoplasty – the method of surgical reconstruction of hymen at the scope of plastic surgery.

Is ECPs are safe medicines with negligible side-effects? First of all it definitely changes the menstruation cycle, which stands the root cause for all adversities to this community. Different medical journals in USA claimed with references that Levonorgestrel can result in Amenorrhea, Erythema, Toxic Shock Syndrome Streptococcal, Myocardial Infarction, Deep Vein Thrombosis, Urticaria, Appendicitis Perforation, Breast Cancer, Bradycardia, apart from the other minor contradictions like Procedural Pain, Nausea, Blood Potassium decrease, Vaginal Haemorrage, Flushing or Abdominal Pain. Dr. Bala a renowned gynecologist claims that regular Hemoglobin test is mandatory to check the Rh status of the users of ECPs. He added that if the mother is Rh negative and the Foetus having Rh positive, then the mother must be given injection to protect her future pregnancies before adopting ECPs. Dr. Abrol says that ECPs causes a drop in hemoglobin level by 1-2%, which as per the statistics is the common cause of Anemia among the womankind. In a word usages of ECPs can affect the hormonal harmonization among the girls, preventing their future opportunities to obtain safe and secured motherhood.

In the year 2007, Tamil Nadu Drug Control Department (TNDCD) issued notice to Cipla for flouting Drugs and Magic Remedies (Objectionable Advertisement) Act for the second time. Only a fine of Rs. 5000 at the Tiruvallur court arranged relief order to Cipla who arranged that negligible penalty gracefully. Compensating virtual crime only with an hour’s earnings, definitely horrendous at this sector where the ‘Life’ of the entire community is concerned. Such judicial phenomenon encourages the Pharmaceutical houses to sell ECPs under Schedule J of the Drugs Act though the Magic Remedies (Objectionable Advertisement) Act 1954 clearly defines in one of its clauses that selling of drugs and medicines through advertisements for the “Procurement of miscarriage in woman or Prevention of conception in woman’ is strictly prohibited.

Actually the Manufacturer organizations are controlling over the administration for self interest. Watch their role for demanding amendments at the Section 36AC of the Spurious Drug Law, 2008. The NPPA website itself attests almost 60% of the fines charged for over-pricing of medicines by the manufacturers are still not recovered. Recently OPPI and IDMA is trying to bring 18% of the formulations under Schedule J from Schedule H, alleging that 65% of the chemists are not maintaining Good Pharmacy Practice (GPP). Are these manufacturers conscious and cautious about their Good Manufacturing Practice (GMP) after getting different sorts of ISO (International Organization for Standardization) certificates?

US FDA warned Ranbaxy Laboratories Limited for violating GMP after the amalgamation with Daiichi, Japan was a disgraceful episode. Bayer challenged Cipla for marketing analogous brand of Nexaver complaining against the viability of the drug indicating the same as ‘Spurious’ as per the amended Drugs & Cosmetics Act 2008. Later on Roche also filed a suit against Cipla for marketing parallel brand of VALCYTE calling the same ‘Spurious & Fake”. In 2009, US FDA detected a dozen of variations at the Bangalore plant of Cipla in the standard operating procedure for GMP quality norms. 15 manufacturing deficiencies were noticed at the Madhya Pradesh unit of Lupin Limited. Caraco Pharmaceuticals, a US subsidiary of Sun Pharmaceuticals was under the scanner of US FDA too. Most disgusting incident is that in June 2009 an Indian Drug Importer was caught by National Agency for Food & Drug Administration and Control (NAFDAC) of Nigeria for supplying substandard Anti-malarial with ‘Made in India’ labeling. As reported further the said Drug was imported from china when the Indian vigilance was quite inactive.

Government is always indolent in imposing penalties or punishments to the industries for violating acts. We doubt if CDSCO has at all initiated valiant steps to reprimand to Glaxo-Smithkline for advertising ‘CERARIX” the newly invented cervical cancer drug. The fallacy is that Dr. Diane Harper one of the prime inventor certified the medicine as not a competent drug. No lawful steps have been taken by any competent authority for violating Rule 106 of Schedule J of the drugs & Cosmetics Act. In India, the manufacturers are still having all legal loopholes to escape from penalties for suppressing proper documents in marketing ‘Narcotic & Psychotropic Drugs’ from CDSCO, yet the traders get punished under the NDPS Act for not maintaining statement of sales properly.

From December 2009, the Government restricted the advertisements of ECPs both at print and electronic media. But Dr. Morepen has promoted more pain with Sonali Bendre to trigger ‘more fikar’ with their newly introduced ECP and smartly publishing their products at the regional cable channels ignoring the vigilance of the DTAB. Recently ‘AYURPIL’ of product of Yousura Herbal is constructing awareness through SMS at Cell-phones about the advantages and adequacy of Ayurvedic Emergency Contraceptive Pill. If the Government is imposing directives to restrict advertisements then how the respective websites related to those products are still alive and active on network! So Progestogen or analogous hormone can be derived even from herbs, plants or floras.

After 61 years of our independence Indians have been blessed with a separate department called Department of Pharmaceuticals under the Ministry of Petrochemicals and Fertilizers. Patients are paying 3% additional Value Added Tax (VAT) for Life Saving drugs than liquor which is quite harmful and invites medication for abrupt dosages. Till date CDSCO has no exclusive guidelines for determining Schedule H drugs. In India one will find several Medicines having irregular combinations of drugs with no scientific legitimacy in medication or therapeutic advice. The prime manufacturing associations oppose newly proposed ‘Uniform Code of Marketing Practices’ (UCMP) which could arrest the unethical marketing practice of bribing doctors. To increase profitability of products under the Controlled category of Drugs Price Control Order (DPCO) manufacturers are selling Multivitamins, Vitamin E as nutrients or dietary supplements. Even after circulars published from the departments like NPPA or DOP, several companies are maintaining unchanged Maximum Retail Price even after enjoying reductions at Excise duties by 4% to 8%.

The infrastructure for dispensing medicines in India is too insufficient considering the actual proportion of 1 Medical store:1500 Indian. OPPI is still very keen to enhance the OTC market by submitting a list of 11 more principal molecules to DCGI for approval. If we scrutinize we must find that Indian market do not carry a healthy infrastructure for OTC brands. The labeling of OTC brands must be written in both local and national languages. The dosages for children if applicable should be specified with quantity, duration and frequency. Adult dosages should not be ambiguous. Inadequate skilled pharmacists among the chemists to serve the OTC brands is a big adversity and Government is still at the preliminary stage of framing qualified Health Workers for proper and perfect health services as determined by W.H.O at their recent circulars.

ECPs have better alternatives at the existing pharmaceutical market, which the doctors endorse and prescribe regularly. Consultation with physicians is a prime part of this medication system. Encouraging ECPs is not only cheering up self-medication but also insisting manufacturers to play with the lives and sentiments of the ailing community. Feeble and incomplete concept about ECPs is misbalancing the harmony of benign hormones of a woman, which may cause infertility or obstructions to the spinsters to feel the divine feelings of motherhood. Snatching the right of the womankind with misleading treatment is to paralyze the ecological system of a country. Mother Teresa said to young people "Keep it pure. Keep your heart virgin. So that on the day of your marriage, you can give something beautiful to each other - the joy of pure love.”

Through ample availability of ECPs, the pharma companies have amplified the appetite among the starved people, particularly among the youth and deserted section who had earlier fright, obligations and indecision to accomplish the desire alongwith their acquaintances. It appears from a survey report in India that sudden augmentation in exhibitionism, voyeurism and chimeral anxiety in such bilateral relation has shadowed the emanating aura causing immense opportunities and imminent dangers simultaneously. ECPs is provoking people into the world of fantasy without plan and resolutions while it is unattainable to drag them out of that labyrinth so long the consequences are turning out as nightmares to them, while maintaining committed relationships.

Medicine is an art of restoring and preserving health, by means of remedial substances. It is a savior to your health not a demolisher. Drugs having reactions or evil effects are synonymous to poison. Invention and Introduction of medicines for procuring the experimental expenses and by defying voluntary and noble attributes shall cause fatal outcome to the human being. Let’s take an oath to protect the future on a vessel of purity by illuminating the torch of consciousness through ‘need-based’ education to consolidate the health of the nation.