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Abbott Laboratories, 297, 345
Abbreviated New Drug Application (ANDA), 17–18, 22, 415
“first-to-file” incentive, 22–25, 274
Ranbaxy’s atorvastatin (ANDA 76–477), 17–21, 23–24, 26–27, 115, 273–87
Ranbaxy’s version of Provigil, 24–25
Acadia National Park, 13
Accum, Frederick, 47
Accutane, 27–30, 112, 153, 415. See also Sotret
Active pharmaceutical ingredient (API), 97, 109, 166, 284, 415
Adulterated food, 47–48, 233–34
Affordable Care Act of 2010, 250
Africa, and AIDS drugs, 81–91
Big Pharma and pricing, 86–90, 93
Bush and PEPFAR, 88–90, 92, 124, 129, 130, 138, 418
Clinton and Clinton Foundation, 36–39, 83, 86, 89, 121–22
Gavini’s inspection of plants, 134–35
Hamied and Cipla, 81–90
McNeil’s New York Times story, 85–87
racism and, 340
Ranbaxy and, 36–37, 38–39, 90, 92, 122, 123–25, 129–30, 134–35, 138, 340
ARV study, 63–65
Africa, pharmaceutical problems in, 337–53
Baker’s India inspections, 339–41
dual-track manufacturing, 340, 343–51
Graham and LaGray, 345–47
“Lazarus Effect,” 344
Lukulay and CePAT, 351–53
Mulago Hospital and Westerberg, 337–39, 341–42
Runnels and, 343–44
Agila Specialties, 321–22, 323, 324–25
Agrawal, Atul, xxii, 294–96, 360–62, 364–68, 373–74
AgVar Chemicals, 77–78, 121–22
AIDS drugs, 81–91. See also Africa, and AIDS drugs
Ranbaxy and, 36–37, 38–39, 90, 92, 122, 123–25, 129–30, 134–35, 138
ARV study, 63–65
AIP. See Application Integrity Policy
ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate), 53
Alcock, Patricia, 190–91, 192
All India Drug Action Network, 343
Altruism, 36
American Chemical Society, 132
American Civil War, 176, 315
American Enterprise Institute, 382
American India Foundation, 37
AmeriSuites Hotel, 161, 163
Amlodipine, 270–71
Amodiaquine, 342
Amoxicillin, 339, 342
Amoxyclav, 65
ANDA. See Abbreviated New Drug Application
Anthrax attacks of 2001, 37–38
Antimicrobial resistance, 350–51
Antitoxin, 48
Appiah, Anita, 344
Application Integrity Policy (AIP), 44–45, 415
Ranbaxy, 186–87, 211–13, 276–77
Sherman Pharmaceuticals, 44–45
Area under the curve (AUC), 97–98, 415
Arlington Memorial Bridge, 315–16
Art of War, The (Sun Tzu), 151
Aseptic manufacturing, 293, 323–24
AsiaMoney, 195
Assize of Bread, 47
AstraZeneca, 112
Toprol XL, 238, 262, 359–60, 419
Ativan, 263
Atorvastatin, 273–89, 418
FDA approval of Ranbaxy, 287–89
Mason’s findings on, 382–83, 456n
Ranbaxy ANDA for, 17–21, 23–24, 26–27, 273–87
Attaran, Amir, 382–83
Aurangzeb Road, 151–52
Autor, Deborah, xxi
Mylan case, 283, 325, 328–29
Ranbaxy case, 187–89, 192, 204–5, 209–10
AZT (azidothymidine), 81–82
Baker, Peter, xxii
at Abbott Laboratories, 297
background of, 296–97
FDA Investigator of the Year Award, 371–72
foreign inspections, 297–98, 403–8
India inspections and reports, 299–309, 339–41, 342, 351, 366–68, 372, 374–75
Fresenius Kabi’s plant, 299–302
HPLC machines, 303–4
Mylan’s Bangalore plant, 323–24
Ranbaxy’s Toansa plant, 293–96, 365–66
Wockhardt’s Chikalthana plant, 359–62, 364
Wockhardt’s Waluj plant, 1–6, 304–7, 397
post-traumatic stress disorder of, 375
update on, 395–96, 403–10
Bangalore plant, 323–25
Bangli Medical Products, 460–61n
Barbhaiya, Rashmi, xx
at BMS, 11–12
departure from Ranbaxy, 61–62, 140
at Ranbaxy, 11–13, 61
Sotret and, 27–28, 91–92
Barton, Joe, 226–27
Batamandi plant, 193–94
“Batch-production record,” 52–63
Bate, Roger, 382
Baxter Healthcare, 227–30
Bayer, 37–38
Beardsley, Kate, 164, 165, 187–88, 199–200, 203, 208
Beato, Andrew, xx
background of, 175–76
Ranbaxy case, 174–78, 252–53, 396
advice on wife Sonal, 252–53, 255–56
first conversation with Thakur, 174–75
first meeting with Thakur, 177–78
Ranbaxy settlement, 312–14, 316–17
update on, 396–97, 399
Beck, Anne, 227
Benazepril, 270–71
Berman, Stuart, xxiii, 245, 250, 279–80, 317–18
Bhagavad Gita, 390
Bhai Traders and Financiers Pvt. Ltd., 74–75
Big Pharma, 22, 326–27, 386
AIDS drugs and, 83, 86–90
Bioavailability, 261
Bioequivalence, xiv–xv, 97–98, 261–62, 267, 270, 415–16, 432–33n
Bioequivalence curves, 97–98, 261–62
Biologics Control Act of 1902, 48
Birth control, 72–73
“Black box” warning on labels, 29
Bombay Legislative Council, 71
Boston University, 350
Bovine spongiform encephalopathy (BSE), 132
Bowker, Gretchen, 224, 231
Brar, Davinder Singh “D.S.”, xix, 386
Clinton visit, 38, 39
Deshmukh and, 26
family fight at Ranbaxy, 78–79, 80
at GVK Bioscences, 386
Ranbaxy’s “Garuda Vision,” 25
Sotret and, 27–28, 30, 386
steps down at Ranbaxy, 60
Bresch, Heather, xxi, 94, 99, 226, 322–23, 326–27
Bristol-Myers Squibb (BMS), 9–12, 57, 103, 104
Barbhaiya at, 11–12
Pravachol, 10, 166, 236
Thakur at, 9–12, 14–16
British colonialism in India, 70–71
Brooklyn College, 77
Brown, Cedric, 241–43
Brown, Regina, xxii, 152–54, 284–85, 286, 287
Budeprion XL, 262–70, 419, 445n
Buehler, Gary, xxii, 260, 262, 265–70
Bulk drugs, 226, 416
Bupropion, 262, 265, 419
Burns, Patrick, 380
Burroughs Wellcome, 71, 82, 264
Bush, George W., 86–87, 88–90, 121
Business Standard, 369
Cadila Pharmaceuticals, 409–10
Calmpose, 75
Cambridge University, 71
Cameron, David, 348
Campbell, Douglas A., xxii
background of, 182–83
Ranbaxy case, 179–82, 205–6, 210, 284, 288–89, 313, 320
AIP, 186–87
whistleblower Sunny emails, 188–90, 191
update on, 400
Canon of Medicine (Ibn Sina), 46
Carrier Corporation, 15, 155
Carvedilol, 237, 416
Caudron, Jean-Michel, 347–48
Ceftriaxone, 337–39, 341–42
Center for Drug Evaluation and Research (CDER), xxii, 132, 143, 185, 186, 187–88, 204–5, 206, 209, 229–30, 246, 260, 282, 283, 359, 372, 407, 416
Division of International Drug Quality, 313, 372, 396
Office of Compliance, xxii, 181–82, 187–88, 278–79, 283, 287, 372
Center for Pharmaceutical Advancement and Training (CePAT), 351–53
Centers for Disease Control and Prevention (CDC), 81, 227, 341–42, 350, 358
Central Drugs Standard Control Organization (CDSCO), xxi, 368–69, 378
Cephalon, Inc., 24–25
Chang, Charles, 222–23, 224
Changzhou SPL, 227–30
Chattaraj, Dipak, 125
Chaudhry, Paresh, 36–39
Chemistry, U.S. Division of, 47–48
Chikalthana plant, xxiv, 359–62, 364, 454n
China, xiii
adulterated food imports, 233–34
heparin adulteration of 2008, 227–30, 234–35, 298
Chromatograms, 185, 189, 281, 282, 300, 373, 416
Cipla Limited, xx, 69–73
AIDS drugs and, 81–90
Clinton visit to Goa plant, 39
history of, 69–73
Ciprofloxacin, 38, 180, 317
Citizen Kane (movie), 13
Civil War, 176, 315
Cleveland Clinic, 233–43, 268, 359, 382, 401–3
Clinton, Bill
AIDS work, 36–39, 83, 86, 89, 121–22
India visits, 36–40, 122
Lewinsky scandal, 174
presidential library opening, 121–22
Clinton Foundation, 38–39, 88, 121–22, 383
Co-amoxiclav, 126
Code of Federal Regulations, Title 21, 1–2, 41, 42
Colliers’ Weekly, 48–49
Colonial India, 70–71
Company culture, xiv
ConsumerLab, 264–65, 268–69
Cooper, Cynthia, 174
Cooperman, Tod, 264–65, 268–69
Coreg, 237, 416
Cornell University, 20
Corrective Action and Preventive Action, 45–46
Cosgrove, Thomas, xxii, 333, 400, 407–8
Counterfeit certification, 234
Counterfeit drugs, 83, 90, 342, 349–50
Country culture, xiv
Couples counseling, 254–55
Coury, Robert, 94, 99, 327
Crawford, Lester, 142–43
CSPC Zhongnuo Pharmaceutical, 341–42
Cuffe Parade, 71
Curium, 132
“Current good manufacturing practices” (cGMP), 2, 5, 46, 52, 98, 287, 416
Daiichi Sankyo, xx, 196–203, 210–17
deal with Ranbaxy, 203, 207–8, 210–11
FDA’s AIP, 211–13
guilty plea, 318–19
interest in stake in Ranbaxy, 196–98
meetings with Ranbaxy, 202–3
meeting with Giuliani Partners, 214–15
meeting with Justice Department, 216–17
resignation of Malvinder, 215–16
SAR and Malvinder, 198–201, 208, 213–14, 318–19, 398, 439n
settlement offer from Justice Department, 312–13
update on, 398–99
Dalian plant, xxiv, 405–6, 460n
Dangerous Doses (Eban), xii
“Data points,” xiv
Defense contractors, 176
Delhi Republic Day parade, 384
Delhi Transport Corporation, 150
Demadex, 236, 416
Deshmukh, Jay, xx
AIP and, 211–13
ANDA for atorvastatin, 23–24, 26–27
background of, 26
Daiichi Sankyo deal, 199, 200, 201–3, 208, 211, 213–14, 398
FDA investigation, 172
FDA meeting, 163–64
Kumar and, 113–14
resignation of, 213–14
SAR and, 165–66, 199, 200, 201–3, 208, 211, 214, 398
update on, 399–400
Valentine’s Day raid, 170
Dewas plant, xxiv
AIDS drugs, 125–26, 129–30
drug testing, 125–26
FDA import restrictions, 209–10
FDA inspections, 147, 153–54, 189–93
whistleblower fraud claims, 398
DHL Express, 306
Diazepam, 344
Diethylene glycol, 50
Dilantin, 260
Dinesh S. Thakur v. Union of India, 391–92
Dingell, John, 223–25
Diovan, 408–9
Diphtheria epidemic of 1901, 48
Dissolution tests, 29, 63, 97, 106, 238, 281
Dr. Reddy’s Laboratories, 240–43, 270–71, 316, 402–3, 409–10, 446n
Doctors Without Borders, xv–xvi, 84, 85, 86, 347, 384
Document forgery, 102, 106–7
Documentum, 60
Dog meat, 43, 46
Donnir, Gordon, 344–45
“Dose dumping,” 264–65
Dressman, Jennifer, 342
Drug Controller General of India (DCGI), 105
Drug Price Competition and Patent Term Restoration Act. See Hatch-Waxman Act
Drug recalls, 52, 209, 227, 237, 238–39, 240–41, 294, 402, 408
Drug resistance, 348–51
Dual-track manufacturing, 340, 343–51
Duffy, Paul, 20
Duke University, 80, 152
Eastern District of New York, 247–48
Eckard, Cheryl, 380
Economic liberalization in India, 78
Economic Times, 203
Edward VIII, 70
Efavirnez, 180
Eli Lilly and Company, 89
Elixir Sulfanilamide, 49–50
Emcure Pharmaceuticals, 400
Enron, 109, 157
EpiPen, 326–27
Equal Employment Opportunity Commission (EEOC), 372
Ergometrine, 345
Eschenbach, Andrew von, 226–27
Ethex, 238–39
European AIDS Conference, 84–85
European Journal of Tropical Medicine and International Health, 348
European Medicines Agency, 384–85, 406
Excipients, 72, 97, 261, 416
Express Scripts, 270–71
Fabiano, Vincent, 169
False Claims Act, 176, 315
FDA (Food and Drug Administration)
AIDS drugs approval, 89–90
background history on, 47–49
“batch-production record,” 52–63
“black box” warning, 29
CDER. See Center for Drug Evaluation and Research
“current good manufacturing practices” (cGMP), 2, 5, 46, 52, 98, 287, 416
defined, 417
Division of Manufacturing and Product Quality (DMPQ), 182–83, 278
Form 483, 44, 133, 367, 417
functions of, 45
generic drug approval, 12–13, 21–23
generic drug manufacturing process, 96–98
generic drug scandal of 1980s, 222–31, 259–60
Generic Drug User Fee Amendment (GDUFA), 322–23
the Graedons and, 259–71
headquarters of, 45
history of, 47, 49–53
import alerts, 228, 372, 417–18
inspections, 44–45. See also FDA, India inspections below
announced, 3–4, 54, 132, 190
China imports, 227–30, 233–34
K&K Seafoods, 41–44
Sherman Pharmaceuticals, 44–45
unannounced, 3, 43, 53–54, 132, 190–91, 364–65, 366–68
investigators, defined, 417
legal authority of, 247
list of individuals at, xxi–xxiii. See also specific individuals
“mutual recognition” strategy, 369–70, 455n
“mutual reliance” strategy, 370–71
Mylan and, 400–401
Chang and, 222–23, 224, 322–23
filing of lawsuit, 282–83
warning letters, 324, 331–32
whistleblower, 328–29, 333–35
Office of Criminal Investigations (OCI), 144, 156–57, 163, 185, 246, 277, 373
Office of Generic Drugs (OGD), 125, 180, 223, 238–39, 242, 260, 269–70, 277, 283–84, 285
Office of Manufacturing Quality (OMQ), 333
Office of Pharmaceutical Quality (OPQ), 359–60
Office of Pharmaceutical Science (OPS), xxii, 274
Ranbaxy case. See FDA, and Ranbaxy case below
Ranbaxy’s atorvastatin ANDA, 17–21, 23–24, 26–27, 273–87
Ranbaxy’s atorvastatin approval, 287–90
Ranbaxy’s Sotret. See Sotret
review system of, 45–46
shared exclusivity, 24–25
FDA (Food and Drug Administration), and Ranbaxy case, 124–27, 246–51
AIP, 186–87, 211–13, 276–77
Campbell and, 179–82, 188–90, 205–6, 288–89
new get-tough stance, 204–6, 209–10
November meeting, 163–66
settlement, 312–14, 316–17
Thakur pseudonymously reaches out to, 142–47, 161–62
theory of the case, 249–51
Valentine’s Day raid, 169–71, 221–22, 247
warning letters, 154, 180, 181, 198, 209, 210
whistleblower Sunny emails, 188–90, 191
FDA (Food and Drug Administration), India inspections, 130–34, 298–99, 303–4, 362–65, 372–74, 396
of Baker, 293–309. See also Baker, Peter
Lal and, 357–59, 362–68, 370–74
list of individuals, xxii
Mylan Laboratories, 93–94
Bangalore plant, 323–25
Nashik plant, 329–32
Pfizer
Dalian plant, 405–6, 460n
Zhejiang Hisun plant, 403–5, 408
pilot program, 364–65, 366–68, 409
Ranbaxy, 152–54
Batamandi plant, 193–94
Dewas plant, 153–54, 189–93
Mohali plant, 111, 280–81
Paonta Sahib plant, 130, 134–35, 152–53, 154, 166–67, 193
Toansa plant, 284–85, 286, 293–96, 365–66
“regulatory tourism,” 362–63
Wockhardt
Chikalthana plant, 359–62, 364, 454n
Waluj plant, 1–6, 304–7
Federal Trade Commission (FTC), 176
Fever 104 FM, 151
“First-to-file” incentive, 22–25, 274
Fluconazole, 180
Food, Drug, and Cosmetic Act (FDCA), 41, 42, 46, 50
Kefauver-Harris Amendment, 51–52
Food additives, 47–48
Food adulteration, 47–48, 233–34
Food and Drug Act of 1906, 49
Food and Drug Administration. See FDA
Forbes (magazine), 150
Form 483, 44, 133, 367, 417
Fortis Healthcare, 399
Fortune (magazine), xiii, 274, 318, 319
Fraud (magazine), 388
Freedom of Information Act (FOI), xviii, 240
Fresenius Kabi, xxiii, 299–302
Frieden, Thomas, 350
Friedman, Martin, 236
Furosemide, 236, 239, 417
Gabapentin, 145, 181–82, 184, 210, 317, 417
Gandhi, Indira, 72–73
Gandhi, Mahatma, 70, 71, 73, 92–93, 99, 351
Garnier, Jean-Pierre, 87
Gates Foundation, 383
Gavini, Muralidhara B. “Mike,” xxii
background of, 131–32
India inspections, 130–34, 298–99, 363
Lal and, 372–74
Ranbaxy’s Paonta Sahib plant, 130, 134–35
Ranbaxy’s guilty plea, 320
Thakur divulges fraud at Ranbaxy, 144
update on, 400
Gemcitabine, 339–41
Generic drugs, xi–xvi. See also India generic drug companies; and specific drugs and drug companies
benefits of, xv–xvi
business model of, 95–96
defined, 417
“first-to-file” incentive, 22–25
the Graedons and, xii, 259–71
harm of, xi–xiii
Hatch-Waxman Act, 21–23, 83, 222, 223–24
manufacturing process, 96–98
quality issues, xiv–xv
Generic Drug Enforcement Act of 1992, 225
Generic drug scandal of 1980s, 222–31, 259–60
Mylan Laboratories, 222–23, 224–26
Generic Drug User Fee Amendment (GDUFA), 322–23
Generic Pharmaceutical Industry Association, 21–22
Gentamicin sulfate, 225–26
Gettysburg Address, 315
Ghalib, 75
Ghana Food and Drugs Authority, 345
Giuliani, Rudolph, 215
Giuliani Partners, 214–15
GlaxoSmithKline, 65, 87–88, 324, 380
Coreg, 237, 416
Wellbutrin XL, 262–67, 269–70, 419
Glenmark, 236–37, 407, 443n
Glimepiride, 145
Global Fund, 383
Globalization, xiii, 31, 55, 182–83
Glossary of terms, 415–19
Glover, R. Derek, 331
Gone with the Wind (movie), 13
“Good manufacturing practices” (GMP), 46, 95, 98, 107, 297, 366
GoogleTalk, 144
Gottlieb, Scott, xxi, 90, 96
Government Accountability Office (GAO), 134, 226
Graedon, Joe, xvi, xxiii, 225, 259–71
doubts about FDA and generic drugs, 260–62, 270–71
as patient advocate, 259–60
seeks author’s assistance, xi, xii
Teva’s Budeprion XL, 262–70
Thakur and, 382, 386
Graedon, Terry, 225, 259–60, 263–65
Graham, Alexandra, 345–47
Grand Hyatt Hotel, 379–80
Grassley, Charles, 191
GRID (gay-related immune deficiency), 81
Gujarat earthquake of 2001, 37, 86
Gurgaon, India, 31–33
GVK Biosciences, 385–87, 456–57n
HAART (highly active anti-retroviral therapy), 82–83
Haddad, William F., xxiii, 21–22, 83–84, 86
Haldol, 344
Haloperidol, 344
Hamburg, Margaret, xxi, 370–71
Hamel, Warren, 215, 216–17
Hamied, Khwaja Abdul “K.A.”, xx, 70–71, 72, 73
Hamied, Yusuf Khwaja “Yuku,” xx, 69–73, 351
AIDS drugs, 81–90, 92
Haryana Urban Development Authority, 31–32
Hatch, Orrin, 22–23
Hatch-Waxman Act, 21–23, 83, 222, 223–24
Health & Human Services (HHS), 190, 358
Heparin, 417
Chinese heparin adulteration of 2008, 227–30, 234–35, 298
Hernandez, Jose, xxiii
background of, 42
domestic inspections, 41–46, 132
K&K Seafoods, 41–44
Sherman Pharmaceuticals, 44–45
foreign inspections, 53–55
Ranbaxy’s Batamandi plant, 193–94
Ranbaxy’s Paonta Sahib plant, 166–67
whistleblower Sunny emails, 183–85
update on, 400
High-performance liquid chromatography (HPLC), 189, 300–301, 303–4, 330, 417
Hisun-Pfizer Pharmaceuticals, 403–5
Hitler, Adolf, 70
HIV (human immunodeficiency virus), 81–82
Holi, 61
Horan, Robert, 152–54
Hospira Healthcare India, 372
House Committee on Energy and Commerce, 221, 223–25, 226–27
House Committee on Oversight and Government Reform, 327
Hubbard, William, 225, 233–34, 234
Hubley, Bonnie, 230
Hubley, Leroy, 230
Hubley, Randy, 230
Husain, M. F., 84
Husain, Zakir, 70
Hypertrophic cardiomyopathy (HCM), 235, 236–37, 239
Ibn Sina, 46
Impax Laboratories, 262–63, 269
Import alerts, 228, 372, 417–18
India generic drug companies, xii–xiii. See also specific companies
AIDS drugs, 81–91
Baker inspections, 293–309
Cleveland Clinic and Lever, 233–43, 268
“Gandhian innovation,” 92–93, 99
the Graedons and, xii, 259–71
history of, 69–80
Indian Drug Manufacturers’ Association (IDMA), 72–73
Indian independence, 71
Indian Independence Day, 141
Indian Patents Act of 1970, 73
Indian Pharmaceutical Alliance, 392
Indian Supreme Court, 390–92, 399
Indira Gandhi International Airport, 17
Infosys Technologies, 155–56, 157, 162
Inter American University of Puerto Rico, 42
Internal Revenue Service (IRS), 157
International Court of Arbitration, 217, 319, 398–99
Isotretinoin, 184, 415. See also Accutane; Sotret
Jamia Millia Islamia, 70
Japan, pharmaceutical industry in, 196–97. See also Daiichi Sankyo
Jasim House, 71
Joe A. Callaway Award for Civic Courage, 319, 389
Johnson, Brian, 403–4
Johnson & Johnson, 98
Jones, Christine, 237
Jordan, Kristy, 402–3
Joshi, P. S., 115
Journal of Clinical Lipidology, 382–83
Journal of the Patent and Trademark Office Society, 26
Jugaad, 99, 231–32
Juneja, Sandeep, 129
Jungle, The (Sinclair), xv
Justice Department, and Ranbaxy case
consent decree, 249–51, 287
Daiichi Sankyo and, 198, 200, 202, 209, 210, 211, 212, 216–17
filing of motion, 204, 207, 221
guilty pleas, 317–20
jurisdiction, 246–47
list of individuals at, xxiii. See also specific individuals
“Princeton Headquarters” spreadsheet, 248–49
settlement efforts, 278–80, 287, 312–14
settlement hearing, 314–18
settlement offer, 245–48
theory of the case, 249–51
Kalyani plant, xxiii, 299–302
K&K Seafoods, 41–44
Kantipudi, Manni, 387
Kaposi’s sarcoma, 81
Kasowitz, Benson, Torres LLP, 399
Kasthuril, Dinesh, 16, 58–59, 60, 108–9, 156
Kefauver, Estes, 21
Kefauver-Harris Amendment, 51–52
Kelsey, Frances, 51
Kennedy, Ted, 89
Kevadon, 51
Khanna, Tejendra, 115, 171
Khorakiwala, Habil, 421–22n
Kobe Steel, 395–96
Kohlberg Kravis Roberts, 386
Kolar, Kevin, 53, 93–94
Komfo Anoyke Teaching Hospital, 344
Kumar, Arun, xx
AIDS drugs, 124–25, 126, 129
Thakur and preliminary findings of fraud, 102–5, 433–34n
Kumar, Rajinder “Raj,” xx, 62–65, 316
background of, 62
board presentation of fraud (SAR), 115–17, 146, 165–66, 171, 172, 318–19
FDA investigation, 172, 281
findings of fraud and ARV drugs study, 63–65
lawyer meeting about fraud, 113–14
preliminary report of fraud, 108–10, 113, 114–15
resignation from Ranbaxy, 116–17, 145
Thakur and, 62–65, 108–10, 114–15, 145–46, 171, 316
Kumar, Vijay, 34–36, 141
KV Pharmaceutical, 238
Kwame Nkrumah University of Science and Technology, 344
Kytril, 128
Lachman Consultant Services, 110–11
LaGray Chemical Co., 345–47
Lal, Altaf, xxii
at FDA India office, 357–59, 362–65, 370–74
India pilot program, 364–65, 366–68, 409
“mutual reliance” strategy, 370–71
“Statement of Intent,” 370–71
termination of, 373–74
update on, 399–400
Lamivudine, 82–83, 129, 134–35
Lartey, Paul, 345–46
Lasix, 417
Lasker Award, 10
Lauwo, Jackson, 342
“Lazarus Effect,” 344
Lead paint poisoning, 226
LeBlaye, Olivier, 63–64, 385, 387
Lever, Harry, xxiii, 233–43, 262, 268, 359–60, 382, 401–3
Lewinsky, Monica, 174
License Raj, 74–75
Lincoln, Abrahm, 315
“Lincoln Law” (False Claims Act), 176, 315
Lincoln Monument, 315
Linhardt, Robert, 228
Lipitor, xiii, 19–21, 418. See also Atorvastatin
Ranbaxy ANDA for, 17–21, 23–24, 26–27, 199, 273–87
Ranbaxy atorvastatin approval, 287–90
London & Mead, 200, 208–9
Love, Jamie Packard, 84, 87
Loveland, Douglas, 144
Lukulay, Patrick H., 55, 340–41, 351–53
Luminal, 50
McCain, John, 89
MacLean, Emi, xv
McNeil, Donald G., Jr., 85–87
Mad cow disease, 132
Madoff, Bernie, 380
Mahabharata, 139
Majeedia Hospital, 58–59
“Make in India,” 384–85
Malaria, 71, 349, 358, 400
Malik, Rajiv, xxi
at Matrix, 92, 93
at Mylan, 93, 94–96, 98–99, 321–22, 324–25, 326, 328, 332, 334–35, 400
at Ranbaxy
departure, 92
reverse-engineering, 28, 91–92
Sotret testing, 28–30, 91–92
update on, 400–401
Manchin, Joe, 94, 322, 327
Mandela, Nelson, 83, 87
Marine Hospital Service, 48
Markopolos, Harry, 380
Marks, Linda, xxiii, 248–49, 280
Maryland U.S. Attorney’s Office, xxiii
consent decree, 249–51, 287
filing of motion, 204, 207, 221
jurisdiction, 246–47
settlement efforts, 278–80, 287, 312–14
settlement hearing, 314–18
settlement offer, 244–48
theory of the case, 249–51
Mashelkar, Raghunath Anant, 92–93, 99, 231
Mason, Preston, 382–83, 456n
Matrix Laboratories, 92–93, 94–96, 147
Maximum City: Bombay Lost and Found (Mehta), 231–32
Max India, 77–78
Mead, Christopher, 200, 208–9
Medicaid, 242, 246, 315
Medicare, 402–3
Mehrauli-Gurgaon Road, 33–34, 35, 141
Mehta, Suketu, 231–32
Merck
Corrective Action and Preventive Action, 45–46
EpiPen scandal, 326–27
Merkel, Angela, 386
Merrell, William S., 51
Metoprolol succinate, 2–3, 238–39, 359, 402, 419
Michigan State University, 352
Middle Ages, 46–47
Ministry of Health and Family Welfare, xxi, 377–79, 393
Modi, Narendra, 384–86
Mohali plant, xxiv, 111, 280–81, 288–89, 398
Morphine, 49
Motz, J. Frederick, 317–18
Mulago National Referral Hospital, 337–39, 341–42
“Mutual recognition,” 369–70, 454n
“Mutual reliance” strategy, 370–71
Myers, Jeffrey, 19–21
Mylan Laboratories, 93–96, 321–35
acquisition of Agila, 321–22, 323, 324–25
acquisition of Matrix, 94–96, 147
ANDA for Provigil, 24–25
Chang and FDA, 222–23, 224
EpiPen scandal, 326–27
FDA inspections, 93–94
Bangalore plant, 323–25
Nashik plant, 329–32
FDA warning letters, 324, 331–32
filing of lawsuit against FDA, 282–83
generic drug scandal of 1980s, 222–23, 224–26
list of individuals at, xxi. See also specific individuals
manufacturing plants, xxiii
Morgantown plant, 93–94, 98, 330, 332–33, 400–401
reputation of, 93–96, 99, 322–23, 326
update on, 400–401
whistleblowers, 328–29, 333–35
Nashik plant, xxiii, 329–32
National Catholic Health Service, 344
National Chemical Laboratory (Pune), 99
National Company Law Tribunal (NCLT), 399
National Highways Authority of India (NHAI), 140–41
National Institutes of Health, 48, 358
National Medal of Technology and Innovation, 10
National Public Radio, 233, 259–60
Nazi Germany, 70
NDMA, 408–9
Nelson, David, xxi, 221–23
heparin scandal, 228–30
Mylan case, 222–23
Ranbaxy case, 221–22, 231–32, 396–97
Nevirapine, 82–83, 85
Newark Airport, 17, 18
Newton, Paul, 349
New York Herald Tribune, 21
New York Times, 85–87
Nichols, Roann, 280
Nickerson, Jason, 341–42
Nissen, Steven, 268
No Action Indicated (NAI), 44, 135, 418
Norton, Marci, xxi, 284–87
Novartis, 238
Obama, Barack, 250
Official Action Indicated (OAI), 44, 285, 333, 407, 409, 418
Ofori-Kwakya, Kwabena, 344
Ohm Laboratories, xxiv, 111, 277
Olanzapine, 344
Out-of-specification (OOS), 181
Oversulfated chondroitin sulfate (OSCS), 228–29
Oxytocin, 345
Pant, Abha, xx, 103, 172
AIDS drugs and, 125
ANDA for atorvastatin, 18
ANDA for Provigil, 24–25
FDA meeting, 163–65
Self-Assessment Report (SAR), 165–66, 208–9
Sotret investigation report, 30, 170–71
Thakur and, 103, 256–57, 388–89
undeclared drugs and customs, 127
Paonta Sahib plant, xxiv, 18
AIDS drugs, 129–30, 134–35, 138
AIP against, 186–87, 211–13, 276–77
FDA import restrictions, 164, 194, 205, 209–10
FDA inspections, 130, 134–35, 147, 152–53, 154, 166–67, 193, 277
FDA warning letters, 198
whistleblower Sunny emails, 183–86, 188–90, 191
“Paragraph IV certification,” 19
Parexel Consulting, 164–65, 179–80, 188, 204, 210, 211
Parnell, Kevin, 239–40
Par Pharmaceutical, 238
Patent laws, 12, 72–73, 96
Hatch-Waxman Act, 21–23, 83, 222, 223–24
Indian Patents Act of 1970, 73
“paragraph IV certification,” 19
Patient Protection and Affordable Care Act of 2010, 250
Patriot Act, 127
Paxil, 62
Pentagon fraud, 176
People’s Pharmacy, The, xi, xii, xvi, 225, 259–60, 262–63, 264, 359, 382
PEPFAR (President’s Emergency Plan for AIDS Relief), 88–90, 92, 124, 129, 130, 418
Pfizer, xiv, 273–74, 324
Dalian plant, 405–6, 460n
Lipitor. See Lipitor
manufacturing plants, xxiv
Ringaskiddy plant, xxiv, 20, 284
tetracycline, 21
Zhejiang Hisun plant, 403–5, 408
Phadke, Anant, 343
Pharmaceutical industry in India. See India generic drug companies
Pharmaceutical Manufacturers Association of South Africa, 83
Pharmacopoeia, 47, 49
Pipi de chats, 37–38
Pisani, Elizabeth, 350
Pittsburgh Post-Gazette, 327
Plavix, 10, 12
Pliva, 236
Pravachol, 10, 166, 236
Pravastatin, 154, 166–67, 236–37, 418
Prescription Drug User Fee Act (PDUFA), 460n
Preservatives, 47–48
Presidential election of 2016, 326
“Princeton Headquarters” spreadsheet, 248–49
“Process validation,” 53
Prograf, 241–42, 402, 418
Provigil, 24–25
Puskar, Mike, 93
Quad Pharmaceuticals, 224, 230–31
Quality Institute, 350
Quinine, 71
Quintiles Consulting, 277–78, 279
Qui tam, 176
Racism, 340
Radha Soami Satsang Beas (RSSB), 149–50, 152
Radithor, 49
Ramachandran, Raju, 391–92
Ramayana, 139
“Ranbaxy Family Feud,” 151–52
Ranbaxy Laboratories
acquisition by Sun Pharmaceuticals, 398–99
AIDS drugs, 36–37, 38–39, 90, 122, 123–25, 129–30, 134–35, 138
ARV study, 63–65
ANDA for atorvastatin (ANDA 76–477), 17–21, 23–24, 26–27, 115
ANDA for Provigil, 24–25
Barbhaiya at, 11–13, 61–62
Clinton and, 36–39, 121–22
Daiichi Sankyo merger. See Daiichi Sankyo
FDA and
AIPs, 186–87, 211–13, 276–77
Campbell and, 179–82, 188–90, 205–6, 288–89
new get-tough stance of FDA, 204–6, 209–10
November meeting, 163–66
sense of crisis, 207–12
theory of the case, 249–51
Valentine’s Day raid, 169–71, 221–22, 247
warning letters, 154, 180, 181, 198, 209, 210
FDA inspections, 152–54
Batamandi plant, 193–94
Dewas plant, 153–54, 189–93
Mohali plant, 111, 280–81
Paonta Sahib plant, 130, 134–35, 152–53, 154, 166–67, 193
Toansa plant, 284–85, 286, 293–96, 365–66
first-to-file applications, 23–25, 26–27, 274
“Garuda Vision,” 25
global sales, 12, 122
guilty plea of, 317–20
Gurgaon campus of, 31–32, 33–34
history of, 73–80
illegal ferrying of drugs, 126–28
Justice Department case. See Justice Department, and Ranbaxy case
Kumar’s board presentation of fraud (SAR), 115–17, 146, 165–66, 199–201, 208–9, 212–13, 215, 318–19
Lachman audit, 110–11
lies and efforts to conceal, 122–30, 207–8
list of individuals at, xix–xx. See also specific individuals
Malvinder as CEO, 149–52, 195–203
manufacturing plants, xxiv. See also specific plants
Parexel audits, 164–65, 179–80, 188, 204, 210, 211
Patient Safety Department, 110–11
preliminary findings of fraud, 101–9, 114
preliminary report of fraud, 108–10, 114–15
records retention policy, 59–60
refrigerators, 123–24, 135, 152–53, 154, 164–65, 284
settlement efforts, 278–80, 287
settlement hearing, 314–18
settlement offer, 244–48
Sotret and. See Sotret
Spreen’s findings of fraud, 112–13
Thakur’s efforts to transform culture of, 57–62
Vimta audit, 63–65, 115–16, 123
whistleblowers, 363, 398
Sunny emails, 183–86, 188–90, 191
Thakur pseudonymously divulges fraud, 141–47
Ranbaxy World, 122
Rao, Rama, 82
Raokheri warehouse, 190, 192
Rapid Action Force (RAF), 196
Raymond, Christopher, 349–50
Reagan, Ronald, 23
Recombinant human insulin, 1–6, 304–7
Reddy, Konduru Narayana, 385–86, 456–57n
Reddy, Prashant, 391–92
“Regulatory tourism,” 362–63
Religare Enterprises, Ltd., 399
Rensselaer Polytechnic Institute, 228
Reverse-engineering, 28, 91–92, 96–97
Rhoades, Bob, 278
Rifampicin, 350
Ringaskiddy plant, xxiv, 20, 284
Riomet, 112
Risperidone, 344
Ritalin, 260
Rivera-Martinez, Edwin, xxii
assignment memo to begin investigation, 146–47
Campbell and, 181, 182
Justice Department files motion, 204
November meeting with Ranbaxy, 164
Ranbaxy’s Dewas plant inspection, 190–91
Thakur and, 154
pseudonymously reaches out to FDA, 143–47
Robertson, Debbie, xxiii, 396
background of, 157
Justice Department and, 246–49
theory of the case, 250–51
“Princeton Headquarters” spreadsheet, 248–49
Ranbaxy ANDA, 274, 278, 281
retirement of, 311–12
Thakur and, 156–57, 171, 251, 311–12, 317–18
meetings, 161–63, 173–74
update on, 399
Valentine’s Day raid, 169–71
whistleblower Sunny emails, 185–86, 188–90, 191
Roche
Accutane, 27–30, 112, 153, 415
Demadex, 236, 416
Valium, 75
Roosevelt, Franklin D., 49
Rosa, Carmelo, xxii, 313, 372, 396
Rosenstein, Rod, 319–20
Roxane, 239
Royal Bank of Scotland, 253
Royal College of Surgeons, 62
RPG Life Sciences, 299
Runnels, Sean, 344
Sabarmati Ashram, 70
Safe Medicines Coalition, 383
St. Louis Children’s Hospital, 227
St. Louis Health Department, 48
Samtani, Lavesh, 216
Sandoz, 19, 238, 242
San Francisco State University, 297
Sankyo Company, 196
SAR (Self-Assessment Report), 115–17, 146, 165–66, 199–201, 212–13, 215, 419
Sawhney, Arun, xix, 288
Sciformix, 252, 313
S.E. Massengill Company, 50
Search warrants, 189, 247–48
Ranbaxy Valentine’s Day raid, 161–62, 170, 171, 172, 184, 200, 245
Secret Service, U.S., 36, 37
Securities and Exchange Board of India (SEBI), 361–62
Securities and Exchange Commission (SEC), 104, 380
Seife, Marvin, 23, 223–24, 441n
Self (magazine), xii
Senate Anti-Trust and Monopoly Subcommittee, 21
September 11 attacks (2001), 15, 37–38
Shah, Dilip, 231
Shah, Dipesh, 360–62, 365–66
Shanghai Desano Pharmaceuticals Co., 346–47
Shared exclusivity, 24–25
Sharma, K. L., 393
Shepherd, Raymond, 208
Sherman Pharmaceuticals, 44–45, 425n
Shiv Sena, 214
Shkreli, Martin, 326–27
Shoda, Takashi, 197
Simons, Bright, 345, 351
Sinclair, Upton, xv
Singh, Analjit, 77–78, 151–52
Singh, Bhai Mohan, xix, 73–79, 151
Singh, Gyanendra Nath “G. N.”, xxi, 368–69, 371, 386, 391, 397
Singh, Malvinder, xix, 246–47
AIDS drugs, 122, 123–24, 126
Daiichi Sankyo merger and, 196–203, 207–8, 210–14, 439n
death of father and, 79–80
Deshmukh and, 199, 200, 201–3, 208, 211, 213–14, 398
education of, 149–50
FDA meeting, 161, 163–66
guilty plea of, 318–19, 397
Kumar’s board presentation of fraud (SAR), 115–17, 165–66, 199–201, 208–9, 215
lies and efforts to conceal, 113, 128–29, 171, 202, 207–8, 217
role as CEO, 149–52, 195–203
sense of crisis at Ranbaxy, 207–8, 210–12
Tempest as CEO, 60–61
update on, 398–99
Singh, Manjit, 77–78
Singh, Nimmi, 149–50, 151–52
Singh, Parvinder, xix, 75–80, 149
company portrait of, 33–34, 63
Deshmukh and, 26
education of, 75–76
Singh, Shivinder, 79, 150–51, 196, 203, 398–99
Skype, 144
SmithKline Beecham, 62
“Smoking gun theory,” 281–82
Sobti, Atul, xix, 278
“Soluble and Immobilized Catalase” (Thakur), 13
Sotret, 27–30, 209–10, 415
FDA inspections and findings, 153, 154, 165, 170–71, 185, 209–10
launch of, 28–30
Malik and failed tests, 28–30, 91–92
Pant and investigation report, 30, 170–71
Ranbaxy fraud and settlement, 317
Spreen and failed data, 112–13
whistleblowers on, 185
South Africa, AIDS drugs, 63–65, 83, 87–88
Spreen, Kathy, 112–13
Stability testing, 109–10, 123, 124, 125, 126, 135
Starling, Randall, xxiii, 240–43, 402–3
Stavudine, 82–83
Stearn, Douglas, 279
Stein, Jacob, 174
Stein, Mitchell, Muse & Cipollone LLP, 174–75, 176, 252–53, 312, 399
Stotland, Nada, xii
Stouffer, Carla, 270–71
Substandard drugs, 115, 341–50, 419
Sulfanilamide, 49–50
Sulfathiazole, 50
Sun Pharmaceuticals, 398–99
Swaminathan, Venkat, 16, 58, 60–61, 109, 117
Synthroid, 260
Syracuse University, 15
Tacrolimus, 193–94, 240–43, 402, 418, 444n
Taj Mahal, 39–40, 362–63
Taj Mahal Palace (Mumbai), 333–34
Takahashi, Karen, xxii, 144, 163, 273–79, 281–82, 289, 313
Tave, Steven, xxi, 249, 250–51, 279
Taxpayers Against Fraud Education Fund (TAFEF), 173–74, 380
Taylor, Paige, 280
Tempest, Brian, xix, 121
AIDS drugs, 39, 63, 64, 124–25, 126
Kumar’s board presentation of fraud (SAR), 115–17, 146, 200
lies and efforts to conceal, 128–29, 217
preliminary report of fraud, 109–10
promotion to CEO, 60–61, 149
Sotret launch, 27–28
Temple, Robert, xxii, 260, 263–70
Tetanus, 48
Tetracycline, 21
Tetzlaff, Ron, 164–65
Teva, 19, 24
Budeprion XL, 262–70, 419, 445n
Thakur, Dinesh, xx
appearance of, 9
Beato and, 174–78, 274, 312–14, 396
advice on wife Sonal, 252–53, 255–56
first conversation with, 174–75
first meeting, 177–78
at BMS, 9–12, 14–16
challenges of living in India, 32–33
childhood of, 13, 138–40
consulting work of, 138, 155
drunk pedestrian incident, 35–36, 141
education of, 13–14, 138–40
efforts to reform India drug industry, 377–79, 382, 383–84, 387, 389–93, 397
at Infosys, 155–56, 157, 162
moral dilemmas of, 139–40, 141
Pant and, 103, 256–57, 388–89
police registration in India, 32–33
at Ranbaxy, 11–13, 16, 32–33, 36, 61–63
Arun Kumar and, 102–5, 433–34n
ARV drugs study, 63–65
Clinton visit, 38, 39
efforts to transform culture, 57–62
findings of fraud, 101–9, 114, 117–18, 137–38
Raj Kumar and, 62–65, 108–10, 114–15, 145–46, 171, 316
records retention policy, 59–60
resignation, 117–18, 137–38
Ranbaxy settlement, 312–14, 377–78
Ranbaxy settlement hearing, 314–18
as Ranbaxy whistleblower, 173–74, 176–78
awards for, 319, 379–81
meetings, 161–63, 173–74, 177–78
pseudonymously reaches out to FDA, 141–47, 161–62
seeking a lawyer, 173–74
Robertson and, 156–57, 161–67, 171, 251, 311–12, 317–18
meetings, 161–63, 173–74
Sciformix, 252, 313
Sonal and family life. See Thakur, Sonal
Thakur, Ishan, 15, 32, 34, 65, 118, 155–56, 314, 381, 390
Thakur, Mohavi, 154–55, 171, 253, 314, 381
Thakur, Sonal Kalchuri, xx
education of, 14–15
marriage and family life, 14, 107–8, 138, 154–56, 252–57, 319, 381–82, 387–89, 397
Ranbaxy case, 117, 171–72, 252–53, 255–56, 313, 397
Thalidomide, 51
Thomas, Mathew, 410
Title 21 of the Code of Federal Regulations, 1–2, 41, 42
Toansa plant, xxiv, 286, 289, 398
FDA inspections, 284–85, 286, 293–96, 365–66
Tobias, Randall, 89
Toprol XL, 238, 262, 359–60, 419
Torsemide, 236, 416
Treatise on Adulterations of Food, and Culinary Poisons (Accum), 47
TRIPS (Trade-Related Aspects of Intellectual Property Rights), 83
Une, Tsutomu, xx, 196–203, 210–13
deal with Ranbaxy, 203, 210–11
FDA’s AIP, 211–13
guilty plea, 319
interest in stake in Ranbaxy, 196–98
meeting with Giuliani Partners, 214–15
meeting with Justice Department, 216–17
meeting with Ranbaxy, 202–3
SAR and Malvinder, 197–201, 213, 214, 319, 398
UNICEF, 123–24, 129, 347
Unitech World Spa, 256–57
United States Pharmacopeia (USP), 49, 55, 238, 340–41, 345, 349–50
University of Arkansas, 131
University of Cincinnati, 242
University of Dundee, 62
University of Michigan, 75–76
University of New Hampshire, 13
University of Papua New Guinea, 342
University Teaching Hospital of Kigali, 343
U.S. Agency for International Development (USAID), 141–42, 192–93, 345
Vaish at Rivoli (New Delhi), 150–51
Valium, 75
Valsartan, 408–9
Vardhan, Harsh, xxi, 377–79
Varis, Agnes, 77–78, 83–84, 121–22
Venable LLP, 208, 215–17
Vimta Labs Ltd., 63–65, 115–16, 123, 385
Virus-Toxin Law of 1902, 48
Voluntary Action Indicated (VAI), 4, 44, 333, 407, 419
Wall Street Journal, 87, 269
Waluj plant, xxiv, 1–6, 304–7, 397
Warning letters, 297, 419
Washington Guest Suites Hotel, 314, 316
Waxman, Henry, 22–23
“We Are the Champions” (song), 318
Wellbutrin XL, 262–67, 269–70, 419
Westerberg, Brian, 337–39, 341–42
West Virginia University, 327
Whistleblowers, 140–41, 308
False Claims Act, 176, 315
GVK Biosciences and Reddy, 385–87, 456–57n
Mylan Laboratories, 328–29, 333–35
Ranbaxy “Sunny” emails, 183–85, 188–90, 191
Satyendra Dubey case, 140–41
Thakur and, 173–74, 176–78, 319, 379–81
pseudonymously reaches out to FDA, 141–47, 161–62
Wiley, Harvey, 47–48, 49
William J. Clinton Presidential Library and Museum, 121–22
Wilmering, Karen, 236–37, 443n
Winthrop Chemical Company, 50
Wire, The, 397
Wockhardt Ltd., 397, 402
FDA inspection of Chikalthana plant, 359–62, 364, 454n
FDA inspection of Waluj plant, 1–6, 304–7, 309
manufacturing plants, xxiv
Woodcock, Janet, xxii, 209, 229–30, 359, 456n
Woods Hole Oceanographic Institution, 131–32
WorldCom, 174
World Health Organization (WHO), 72–73, 89–90, 124–25, 141–42, 343
Vimta Labs inspection, 63–65
World Spa West, 381–82, 387–89
World Trade Organization (WTO), 83
World War II, 71, 74
Wyden, Ron, 223
Wyeth, 112, 352
Young, Frank, 223
Zaman, Muhammad, 350
“Zero Defect, Zero Effect,” 384–85
Zhejiang Hisun plant, xxiv, 403–5, 408
Zhejiang Huahai Pharmaceuticals, 408–9
Zidovudine, 134–35, 144–45
Zydus, 237